Food Recalls

[Kitchen Witch]

Ketek (telithromycin)
Audience: Infectious Disease, Hepatology and other healthcare professionals
[Posted 01/20/2006] Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases were also reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. As a part of this, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

[January 20, 2006 ? Public Health Advisory ? FDA]
[January 20, 2006 ? Questions and Answers ? FDA]



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State Health Department Issues Warning on Juice Harvest Assorted Juices

Contact:
Ken August or Lea Brooks
(916) 440-7660

FOR IMMEDIATE RELEASE -- Sacramento, CA -- January 20, 2006 -- Consumers should not drink Evolution, Harvest or Trader Joe's brand assorted juices manufactured by Juice Harvest Corp. of San Bernardino because the products were not fully pasteurized and may contain harmful bacteria that pose a health risk, State Public Health Officer Dr. Mark Horton announced today. The containers list the following code dates: "1-12, 1-14, 1-17, 1-20 or 1-23." No illnesses associated with these products have been reported.

Approximately 8,000 units of the assorted juices in 16-, 32- and 64-ounce packages and one{omitted}gallon plastic containers distributed in Southern California are being voluntarily recalled. Customers who have purchased these products should return them to the place of purchase or dispose of them immediately. The California Department of Health Services is investigating to determine which distributors and retail establishments received these products.

The assorted juices being recalled are:

BRAND

NAME OF PRODUCT

CODE DATE

SIZE

Evolution, Harvest

Carrot Juice

1-12

16 oz, 32 oz

Evolution, Harvest

Organic Carrot Juice

1-12

16 oz, 32 oz

Evolution, Harvest

Carrot Celery Beet

1-12

16 oz

Evolution, Harvest

Carrot Parsley Spinach

1-12

16 oz

Evolution, Harvest

Incredible Vegetables

1-12

16 oz

Evolution, Harvest

Organic V

1-12

16 oz

Evolution

Essential Greens

1-14

16 oz

Evolution, Harvest,

Watermelon Juice

1-14

32 oz, 16 oz

Trader Joe's







Evolution, Harvest

Acai

1-14

16 oz

Evolution

SuperGreen

1-17

16 oz

Evolution

Orange Juice Past

1-20

32 oz, 64 oz

Evolution, Harvest

Old-Fashioned Lemonade

1-23

64 oz, 1 gal

Evolution, Harvest

Organic Lemonade

1-23

16 oz, 32 oz

Trader Joe's

Defense UP

1-17

16 oz

Evolution, Harvest

Bee Enerqized

1-17

16 oz

For more information about the products, consumers may contact Juice Harvest Corp. at (909) 478-0895.

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Pinnacle Foods Group Inc. Issues Allergy Alert on Undeclared Egg in Frozen "Aunt Jemima® Cinnamon French Toast" 12.5 oz. Cartons and Frozen "Aunt Jemima 'Home-Style' Low Fat Waffles" 20 oz. Cartons

Contact:
Mr. Kelley Maggs
973-541-6640

FOR IMMEDIATE RELEASE -- Mountain Lakes, NJ -- January 20, 2006 -- Pinnacle Foods Group Inc. of Mountain Lakes, NJ is recalling only the following products: Frozen AUNT JEMIMA CINNAMON FRENCH TOAST 12.5 oz. cartons and Frozen AUNT JEMIMA 'HOME STYLE' LOW FAT WAFFLES 20 oz. cartons with the lot codes listed below.

These products were manufactured with egg that is not listed on the carton. People who have an allergy or severe sensitivity to egg may run the risk of a serious or life-threatening allergic reaction if they consume this product.

This voluntary recall was initiated after the Company received an email from a consumer informing the Company that egg was not listed on the carton.

Retail Carton Code

Description - Retail Label Weight

Recommend Use By Date
(lot codes on or after are the issue)

19600-05130

AJ Low Fat Homestyle Waffle - 20 oz.

November 17, 2006

19600-05890

AJ French Toast Cinnamon - 12.5 oz.

June 12, 2006

If you are allergic to or have a severe sensitivity to eggs, you should not consume this product. Please return the product to the store where purchased for a full refund.

If you are not allergic to eggs, this product is safe to eat.

This announcement does not apply to any other Aunt Jemima frozen ready-to-eat items or other Aunt Jemima products such as pancake mixes or syrups.

Consumers with questions may contact the company at 1-800-554-5680.

The Food and Drug Administration has been made aware of this recall.


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Class 1 Recall: Vapotherm, Inc. Vapotherm® 2000i and 2000h Respiratory Gas Humidifier

Date Recall
Initiated:

October 13, 2005

Product:

Vapotherm® 2000i and 2000h Respiratory Gas Humidifier

Use:

The Vapotherm 2000i and 2000h Respiratory Gas Administration delivers moisture to and warms breathing gases through a flexible nasal tube for patients receiving supplemental oxygen. The environments of use include home, hospital or sub-acute institutional settings.

Recalling Firm:

Vapotherm, Inc.
108 Log Canoe Circle
Stevensville, MD 21666

Reason for Recall:

FDA has received reports of Vapotherm units becoming contaminated with Ralstonia spp, and other bacteria. Exposure to these bacteria may cause patients to develop tracheitis (infection of the trachea), sepsis (infection in the bloodstream), pneumonia (lung infection), or other serious infections. There is a reasonable probability that immunocompromised patients or premature newborms could develop pneumonia, sepsis and in the most severe cases, death.

Public Contact:

David Lain
Chief Regulatory Officer
Vapotherm, Inc.
198 Log Canoe Circle
Stevensville, MD 21012
410-604-3977

FDA District:

Baltimore

FDA Comments:

* FDA recommends the use of alternative devices until the source of the contamination has been identified.
* In October 2005, Vapotherm issued new procedures for disinfecting the Vapotherm® 2000i and 2000h humidifiers, but these procedures have not been effective in eliminating Ralstonia spp. contamination in the devices.
* Patients who have been exposed to the Vapotherm system should be monitored for signs and symptoms that may suggest infection, which may include, but are not limited to:
* changes in temperature;
* poor feeding, irritability; and
* changes in hematologic indices.
* Clinicians may want to consider Ralstonia infection in the differential diagnosis of symptomatic patients even if the organism has not been isolated.



Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.


For additional information, see the FDA?s 12/20/05 Preliminary Public Health Notification at http://www.fda.gov/cdrh/safety/122005-vapotherm.html.
Updated January 23, 2006

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Blooming Import Inc. Issues Allergy Alert on Undeclared Sulfites in Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates)

Contact:
Blooming Import Inc.
Moon Kee Lee
718-625-6868

FOR IMMEDIATE RELEASE -- Brooklyn, NY -- Jan. 24, 2006 --- Blooming Import Inc. 45 Bowne Street, Brooklyn, NY 11231 is recalling Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates) because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allege reactions if they consume this product.

The recalled Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates), packaged in uncoded 12 ounce heat sealed plastic bags were sold in New York City.

The recall was initialed after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of undeclared sulfites in Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates) in packages which did not declare sulfites on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfites sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No Illnesses have been reported to date in connection with this problem.

Consumers who have purchased Golden Lion Brand Dried Ziziphus Jujuba Mill (Dates) should return it to the place of purchase. Consumers with questions may contact the company at 1-800-680-3838.



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[Kitchen Witch]

Food and Drug Administration Seeks Injunction Against Pacific Shellfish, Inc.

The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Pacific Shellfish, Inc., a seafood processor located at 5040 Cass Street in San Diego California, and Judd J. Brown, its President. An injunction is a court order to stop a firm from manufacturing, distributing, processing, or shipping a product. The government's complaint, filed on January 24, 2006 by the U.S. Department of Justice in the U.S. District Court for the Southern District of California, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by permitting ready-to-eat fish held and processed in Pacific Shellfish's facility to become contaminated.

According to the complaint, recent FDA inspections in 2004 and 2005 revealed the presence of Listeria monocytogenes (Listeria), a disease-causing bacterium, on Pacific Shellfish's processing equipment and fish products. Inspections since 2001 have also documented persistent insanitary conditions at the facility. FDA issued a letter to the firm on December 8, 2004, after an inspection revealed insanitary conditions and contamination with Listeria. Although the firm promised to correct its deficiencies, a 2005 inspection found that a persistent strain of Listeria remained and the firm had not implemented all of the promised corrections.

Listeria monocytogenesis the causal agent of listeriosis, a disease that can be very serious, even fatal, for high-risk groups such as pregnant women, unborn babies, newborns, and those with impaired immune systems. Although proper cooking can eliminate Listeria in fish products, raw fish products, such as those found in some types of sushi, pose a serious health risk if contaminated with Listeria. Even if fish is intended to be cooked, however, adequate sanitation is needed to prevent the spread of this strain of Listeria throughout the distribution system to restaurants and consumer homes, where it may contaminate ready-to-eat foods. The Listeria monocytogenes strain isolated from the 2004 and 2005 inspections was identical to a strain that has caused human illness.

The FDA has initiated this action to promote and protect the public health by enforcing the Federal Food, Drug, and Cosmetic Act. FDA's mission includes ensuring the safety or safety and effectiveness of a broad spectrum of regulated products, including food, human and animal drugs, vaccines, blood products, medical devices, electronic products that emit radiation, and cosmetics.


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Recall -- State Press Release
Undeclared Sulfites in Swad Brand Dry Dates

Contact:
Jessica A. Chittenden
518-457-3136

FOR IMMEDIATE RELEASE -- Maspeth, NY -- January 27, 2006 -- Acting Agriculture Commissioner Patrick H. Brennan today alerted consumers that Rajah Foods, 56-05 55th Drive, Maspeth, New York is recalling "Swad brand Dry Dates" due to the presence of undeclared sulfites. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product.

The recalled "Swad brand Dry Dates" are packaged in a 7-ounce, uncoded plastic bag. It was sold throughout New York, New Jersey, Connecticut, Massachusetts, Delaware, Maryland, and Virginia. It is a product of India.

Routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the product contained high levels of sulfites which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No illnesses have been reported to date to this Department in connection with this problem.

Consumers who have purchased "Swad brand Dry Dates" should return them to the place of purchase.

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Hasty Tasty Food Service Recalls Sandwiches Due to Undeclared Allergens

Contact:
Hasty Tasty Food Service Inc.
(563) 333-6783

FOR IMMEDIATE RELEASE -- Davenport, IA -- January 27, 2006 -- Hasty Tasty Food Service Inc./DBA Valley Vending of Davenport Iowa is recalling the following items: Chicken Salad, Egg Salad, Ham Salad, and Tuna Salad sandwiches because they contain undeclared Dairy allergens (sweet dairy whey and butter). People who may have an allergy or severe sensitivity to Dairy products run the risk of serious or life threatening allergic reaction if they consume these products.

The Chicken Salad, Ham Salad, Egg Salad sandwiches were labeled under the brand names of Valley Vending/Hasty Tasty, Venture Vending, Prime Vending, and M & M Vending. Only the Tuna Salad Sandwiches were labeled with the Valley Vending/Hasty Tasty label. The sandwiches were distributed in the states of Iowa and Illinois through our mobile catering trucks and/or vending machines.

These products can be identified by the brand name and are packaged in a plastic wedge container with a date code on or before 1/26/06. The net weight on the label is 4.5 oz.

No illnesses have been reported to date.

The recall was initiated after it was discovered that our sliced bread containing sweet dairy whey and butter was distributed in packaging that did not reveal the presence of these listed allergens on the label. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes. All products have been pulled from distribution and label corrections have been completed.

Anyone with questions concerning this matter may contact Hasty Tasty Food Service Inc./DBA Valley Vending at (563) 333-6783.


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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
The First Years® Announces Voluntary Recall of Liquid-Filled Teethers

Contact:
The First Years Recall Hotline
1-866-725-4407

FOR IMMEDIATE RELEASE -- STOUGHTON, MA -- January 27, 2006 -- The First Years, a subsidiary of RC2 Corporation, is voluntarily recalling liquid filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain pseudomonas aeruginosa and pseudomonas putida which can cause serious illness in children if the teether is punctured and the liquid from the teether is ingested.

Consumers should stop using the recalled products immediately.

Products:

* Disney Days of Hunny Soft Cool Ring Teether--Style# Y1447
* Disney Soft Cool Ring Teether--Style# Y1470
* Disney Soft Cool Ring Teether--Style# Y1490
* The First Years® Cool Animal Teether/Fish, Zebra and Dinosaur designs--Style# Y1473
* The First Years® Floating Friends Teether-- Style# Y1474
* Sesame Beginnings? Chill & Chew Teether-- Style# Y3095

This recall is for 6 different styles of liquid-filled teethers for infants (3+ months old) to soothe gums during the feeding stage. The 6 styles affected have the same general construction of a durable vinyl exterior with clear liquid pre-filled inside. Some designs have printed graphics while others have floating internal characters.

No illnesses have been reported to date in connection with this problem.

The teethers are sold nationwide including major retailers, grocery, drug and specialty stores from July 2005 to January 2006 for $2.99 to $3.99.

Consumers should put the teether in its current condition into a sealed plastic storage bag, place in envelope, and return to: Parent Service Center, RC2/The First Years, 100 Technology Center Drive, Stoughton, Massachusetts, 02072. Consumers should include their mailing address in the envelope to receive a replacement teether and free gift.

Consumer Contact: For additional information, consumers can visit: www.thefirstyears.com or call The
First Years Parent Service Center at 1-866-725-4407.

This recall is being made with the knowledge of the US Food and Drug Administration. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. Or, on the MedWatch web site at www.fda.gov/medwatch.

[Kitchen Witch]

Recall Notification Report 002-2006
[ ]
Product(s) Recalled:
Asian Style Pot Stickers

Production Dates/Identifying Codes:
Produced 09/19/2005

The following product is subject to recall:

* 9-ounce packages of Stouffer's "LEAN CUISINE® ASIAN-STYLE POT STICKERS," chicken & vegetable dumplings with rice in an Asian-Style dipping sauce. Each package contains the package code, "5262595512," the words "Best before Oct. 2006" and the establishment number, "P-7991," printed on the right side flap.


Problem/Reason for Recall:
The product may contain extraneous materials (small hard plastic fragments).

How/When Discovered:
The Company notified FSIS after receiving consumer complaints. There were no reports of injury.

Federal Establishment:
07791 P
Nestlé Prepared Foods Company
2130 Old Georgia Highway
Gaffney, SC 29340

Consumer Contact:
Nestlé Consumer Services, 800-993-8625

Media Contact:
Roz O'Hearn, Manager, Marketing Communications, (440) 264-5170

Quantity Recalled:
Approximately 54,690 pounds

Quantity Recovered:
To Be Determined

Distribution:
Nationwide

Recall Classification:
Class II

Recall Notification Level:
Retail

Press Release:
South Carolina Firm Recalls Asian-Style Pot Stickers That May Contain Pieces of Plastic

Direct Notification Means:
The firm has notified its customers verbally and will follow-up in writing.

FSIS Follow-up Activities:
Effectiveness checks by the FSIS, Office of Field Operations (OFO).

Other Agencies Involved:
None

FSIS Contacts:

* FSIS Recall Coordinator: (919) 844-8400
* Recall Management: (202) 690-6389
* Media Inquiries: (202) 720-9113
* Congressional Inquiries: (202) 720-3897
* Consumer Inquiries: 1-888-MPHotline (1-888-674-6854); TTY, 1-800-256-7072
* Web Site: http://www.fsis.usda.gov/ (FSIS Main Page) or http://www.fsis.usda.gov/FSIS_Recalls/ (Recall Information)


Date of Recall Meeting:
January 23, 2006

Recall Case Number:
002-2006







Recall Notification Report 003-2006
[ ]
Product(s) Recalled:
Sirloin Beef and Asian Style Vegetables

Production Dates/Identifying Codes:
Produced November 11, 2005

The following product is subject to recall:

* 9.0 Oz boxes of "WEIGHT WATCHERS® SMART ONES® SIRLOIN BEEF AND ASIAN STYLE VEGETABLES," in a zesty teriyaki sauce. Each box includes the establishment number, "EST. 1869" inside the USDA mark of inspection and a best if used by date of "11/07." Each box bears the code "MS 5 L 11 BD 2."


Problem/Reason for Recall:
The package indicates that the product is sirloin beef and Asian style vegetables; however, inside the package is roast beef in Portobello vermouth sauce with broccoli and cauliflower. The package labels do not specifically state that milk protein, a potential known allergen, is an ingredient.

How/When Discovered:
The Company received a consumer complaint and reported the incident to FSIS.

Federal Establishment:
01869 M
Heinz Frozen Foods
1301 Oberlin Road S.W.
Massillon, OH 44647

Consumer Contact:
Consumer Affairs Department, 1-800-551-0140

Media Contact:
Robin Teets, Senior Manager, Public Relations, (412) 237-3562

Quantity Recalled:
Approximately 1,561 pounds

Quantity Recovered:
To Be Determined

Distribution:
Florida, Maryland, Missouri, Pennsylvania, Virginia and Washington, DC

Recall Classification:
Class I

Recall Notification Level:
Consumer

Press Release:
Ohio Firm Recalls Sirloin Beef and Asian Style Vegetables Due To Undeclared Allergen

Direct Notification Means:
The firm has notified its customers orally and will follow up in writing.

FSIS Follow-up Activities:
Effectiveness checks by the FSIS, Office of Field Operations (OFO).

Other Agencies Involved:
None

FSIS Contacts:

* FSIS Recall Coordinator: (630) 620-7474
* Recall Management: (202) 690-6389
* Media Inquiries: (202) 720-9113
* Congressional Inquiries: (202) 720-3897
* Consumer Inquiries: 1-888-MPHotline (1-888-674-6854); TTY, 1-800-256-7072
* Web Site: http://www.fsis.usda.gov/ (FSIS Main Page) or http://www.fsis.usda.gov/FSIS_Recalls/ (Recall Information)


Date of Recall Meeting:
January 23, 2006

Recall Case Number:
003-2006





Recall Notification Report 004-2006
[ ]
Product(s) Recalled:
Sausages

Production Dates/Identifying Codes:
The following products are subject to recall:

* 2 ½- and 5-pound jars of "MEXICAN BRAND, MADE IN MICHIGAN, RED HOTS SAUSAGE, SMOKED FLAVOR ADDED, PACKED IN SOLUTION OF VINEGAR AND SALT." Each label includes the establishment number, "EST. 10116" inside the USDA mark of inspection.
* 5-pound jars of "RED HOTS, Smoked Sausage, PACKED IN SOLUTION OF VINEGAR WATER AND SALT." Each label includes the establishment number, "EST. 10116" inside the USDA mark of inspection.


Problem/Reason for Recall:
The product labels do not specifically state that milk, a known allergen, is an ingredient.

How/When Discovered:
The problem was discovered by FSIS.

Federal Establishment:
10116 M
Kubisch Sausage Co.
50400 Rizzo Dr.
Shelby Twp, MI 48315

Consumer Contact:
Vaso Marcovich, President, (586) 566-4661

Media Contact:
Vaso Marcovich, President, (586) 566-4661

Quantity Recalled:
Unknown

Quantity Recovered:
To Be Determined

Distribution:
Michigan

Recall Classification:
Class I

Recall Notification Level:
Retail

Press Release:
Michigan Firm Recalls Sausage Products Due To Undeclared Allergen

Direct Notification Means:
The firm has notified its customers verbally and will follow-up in writing.

FSIS Follow-up Activities:
Effectiveness checks by the FSIS, Office of Field Operations (OFO).

Other Agencies Involved:
None

FSIS Contacts:

* FSIS Recall Coordinator: (60 240-4080
* Recall Management: (202) 690-6389
* Media Inquiries: (202) 720-9113
* Congressional Inquiries: (202) 720-3897
* Consumer Inquiries: 1-888-MPHotline (1-888-674-6854); TTY, 1-800-256-7072
* Web Site: http://www.fsis.usda.gov/ (FSIS Main Page) or http://www.fsis.usda.gov/FSIS_Recalls/ (Recall Information)


Date of Recall Meeting:
January 27, 2006

Recall Case Number:
004-2006

[Kitchen Witch]

Class 1 Recall: Boston Scientific Flextome® Cutting Balloon Systems
Date Recall
Initiated:

December 7, 2005
Product:
Flextome Cutting Balloon® Device Monorail® Delivery System
Use:
The Flextome Cutting Balloon® system is used to open blocked arteries or blood vessels. It consists of a surgical balloon with microsurgical blades attached to the sides. The balloon is inserted into the artery with a catheter, and then dilated. When the balloon expands, the microblades cut through fatty deposits, widening the blocked artery.
Recalling Firm:
Boston Scientific Corporation
3574 Ruffin Road
San Diego, California 92123-2597
Reason for Recall:
The catheter shaft used to place the balloon in the artery may separate during withdrawal of the device from the patient. If that happens, the procedure may be prolonged, or more in-depth surgery may be required to remove the broken-off piece from the artery.
Public Contact:
Abe Matthews
Vice President of Regulatory Affairs
Boston Scientific Corporation
3574 Ruffin Road
San Diego, California 92123-2597
858-254-7885
FDA District:
Los Angeles
FDA Comments:

* This product should no longer be used on patients and should be returned to Boston Scientific.
* This action does not affect patients who have already received treatment, because the problem occurs during the procedure.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.


A copy of the company's press release regarding this recall can be found on the company's website.








Class 1 Recall: Baxter Healthcare Corp. COLLEAGUE® and COLLEAGUE® CX Volumetric Infusion Pumps

Date Recall
Initiated:

December 13, 2005

See also:

* September 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps
* July 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps

Product:

All models of Baxter Healthcare Corp. COLLEAGUE® Volumetric Infusion Pumps.
Affected Models are: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

Use:

These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.

Recalling Firm:

Baxter Healthcare Corporation
Rt. 120 & Wilson Road
Round Lake, IL 60073

Reason for Recall:

Battery Undercharging: The pump?s battery charge level indicator may overstate the battery power level and shut down when operating on battery power if not charged for a full 12 hours following a ?low battery? alarm.
False Air Detection Alarms: If the pump?s tubing is stretched or pulled, the pump?s sensors may misinterpret this tension as air in the line, resulting in a false alarm and shutting down the pump.
Gearbox Wear: Worn parts in the pump?s motor can cause the pump to shut down and interrupt therapy.
Under-infusion: If there is an obstruction during tube-loading, the upper jaw of the pump head can be moved out of alignment, resulting in insufficient fluid delivery.
Non-detection of upstream occlusion: Improperly spiked bags, use of a source container which has had all air removed, improper venting of the container, and an unopened air vent above the burette chamber may result in the pump not detecting an upstream occlusion.

Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for patients, depending on the type of therapy being administered.

Public Contact:

Center for One Baxter
Baxter Healthcare Corporation
1 Deerfield Parkway
Deerfield, IL 60015
800-422-9837

FDA District:

Chicago

FDA Comments:

* FDA has issued previous recall notices for the COLLEAGUE® Volumetric Infusion Pumps. Information explaining the reason for these recalls can be found on the Agency?s web site:
* September 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps
* July 19, 2005 Recall for Baxter COLLEAGUE® Volumetric Infusion Pumps

* Baxter sent a December 13, 2005 Urgent Device Correction Notice to all COLLEAGUE® customers alerting them to the additional problems with the pump identified in this notice. The letter included instructions for reducing the occurrence of these potential problems, and included a copy of the Battery Usage Guide, Infusion Management Guide, and the March 17, 2005 Buretrol Set Urgent Device Correction letter to be distributed to all users of the Colleague pump.

* Baxter also informed customers that they would be notified when the new release of the COLLEAGUE® Volumetric Infusion Pump Operator?s Manual is available.

* COLLEAGUE® customers with questions may contact Baxter?s Medication Delivery Services at 1-800-843-7867.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.



Consumers with questions may contact the company at 800-422-9837, or visit Baxter?s website.

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Ingles Markets, Incorporated Issues Local Recall for Old Fashion Apple Pie

Contact:
Tim Davey
(82 669-2941 (Ext. 391)

FOR IMMEDIATE RELEASE -- Asheville, NC. -- February 3, 2006 -- Ingles Markets, Incorporated of Asheville, N.C., is recalling its 9" Old Fashion Apple Pie because they may contain undeclared walnuts in the pie topping. People who have allergies to walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.

The recall was initiated after it was discovered that some of the pies were mislabeled and did not disclose the presence of walnuts in the topping. The product comes in a clear plastic package marked with the sell by date of January 31, 2006, or before. The recalled 9" Old Fashion Apple Pies were sold in Ingles retail stores located in AL, GA, NC, SC, TN and VA. Customers who have purchased the product may return it to the store for a full refund or replacement. All 9" Old Fashion Apple Pies currently for sale are labeled correctly. Customers with questions may contact Ingles at 1-800-635-5066 extension 426.

[Kitchen Witch]

FDA News

FOR IMMEDIATE RELEASE
P06-19
February 8, 2006

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Issues Public Health Advisory for Trasylol

The Food and Drug Administration today issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasyolol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.

"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients."

FDA advises health care providers to be aware of the following:

* Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or through the FDA Medwatch program.
* Physicians should consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
* FDA is working with the manufacturer to examine the safety and benefits of Trasylol in light of the recent data and the evolving practice of medicine.
* Patients should discuss all major risks for heart bypass surgery with their healthcare providers. These include the risks for bleeding and the available ways to lessen the risk for bleeding.

Trasylol (aprotinin injection) is the only product approved by FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery. The drug aids the body's ability to stop bleeding and is used to lessen the bleeding risk during this surgical procedure. This surgery is done to bypass clogged arteries.
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FDA is evaluating the studies more closely, along with other scientific literature and reports submitted to the FDA through the MedWatch program, to determine if labeling changes or other actions are warranted. One study, published in the New England Journal of Medicine, reported that patients who received Trasylol had higher rates of serious kidney problems, heart attacks, and stroke compared to treatment with other drugs to prevent bleeding or to no treatment; the second study, reported in Transfusion, reported more cases of decreased kidney function in patients treated with Trasylol compared to another treatment to prevent bleeding. A limitation of both studies was that doctors chose which patients were to receive Trasylol or another treatment. It is possible that patients treated with Trasylol may have been sicker than other patients. The studies used complex statistical methods to adjust for possible differences in patient risk factors.

The agency also anticipates convening an advisory committee meeting in 2006 to discuss the existing data about the risks and benefits of Trasylol, and if additional safety measures need to be taken. The FDA will notify health care providers and patients in a timely manner following further scientific investigation of adverse event reports.

FDA also urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1800-FDA-108, by fax (1-800-FDA-107 or internet.

The Public Health Advisory is available on line at http://www.fda.gov/cder/drug/advisory/aprotinin.htm.

For more information please visit http://www.fda.gov/cder/drug/infopag...in/default.htm,

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[Kitchen Witch]

FDA News

FOR IMMEDIATE RELEASE
P06-21
February 9, 2006

Media Inquiries:
Stephen King, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Warns Consumers to Stop Using Recalled Liquid-Filled Children?s Teething Rings Manufactured by RC2 Brands (The First Years)

The U.S. Food and Drug Administration (FDA) is advising consumers to stop using liquid-filled children's teething rings manufactured by RC2 Brands (The First Years) because the liquid contained in these rings is contaminated with bacteria that may cause serious illness if swallowed by babies, enters the lungs, or is absorbed through a cut in the mouth.

The risk of illness is especially high in infants whose immune systems are compromised by underlying issues such as malnutrition, blood problems, or as a result of cancer therapy.

RC2 Brands (The First Years), which is located in Stoughton, Massachusetts, stopped distributing the teethers and began a recall of these products in January 2006.

"FDA is closely monitoring the recall to ensure that all these teething rings are removed from the market and that consumers are alerted to the problem," said Dr. Daniel Schultz, Director of FDA's Center for Devices and Radiological Health. "The agency is also taking a careful look at other RC2/The First Year products to determine if any others are contaminated with the bacteria."

The teething rings were sold nationwide between July 2005 and January 2006 at major retailers, and grocery, drug, and specialty stores. Approximately 352,000 have been distributed in the United States. The specific products subject to the recall are:

* Disney Days of Hunny Soft Cool Ring Teether -- Style #Y1447
* Disney Soft Cool Ring Teether -- Style #Y1470
* Disney Soft Cool Ring Teether -- Style #Y1490
* Sesame Beginnings Chill & Chew Teether -- Style #Y3095
* The First Year's Cool Animal Teether, fish, zebra, and dinosaur designs -- Style #Y1473
* The First Year's Floating Friend Teether -- Style # Y1474

FDA has determined that the firm's action constitutes a Class I recall, a situation in which there is a reasonable chance that use of the product will cause serious health problems or death. To date, the firm has received 105 complaints of fluid leakage, 14 reports of sharp edges that resulted in 9 incidents of cuts, and 2 reports of babies biting through the rings. The teething rings are manufactured in Hong Kong and have been sold in both the United States and Canada.

The firm is asking consumers who purchased one of the recalled teethers to place it in a plastic bag and return it to:

Parent Service Center
RC2/The First Years
100 Technology Center Dr.
Stoughton, Mass., 02072

For additional information, consumers can contact the firm's service center at 1-866-725-4407, or go to the firm's web site: www.thefirstyears.com.

Any adverse reactions or quality problems experienced with use of these teethers should be reported to the FDA MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or on the MedWatch web site at www.fda.gov/medwatch.

[Kitchen Witch]

Benzocaine sprays
Audience: Healthcare professionals and patients
[Posted 02/13/2006] FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia, associated with the use of benzocaine sprays used in the mouth and throat. Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways. On February 8, 2006, the Veterans Health Administration (VA) announced the decision to stop using benzocaine sprays for these purposes. The FDA is aware of the reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market. The FDA is highlighting safety information previously addressed by the Agency (see below), has provided other information for the consideration of clinicians in the PHA and will make further announcements or take action as warranted by the ongoing review.

[February 10, 2006 ? Public Health Advisory ? FDA]
[January 2003 - FDA Patient Safety News - FDA]

[Kitchen Witch]

FDA-Requested Recall - Cytosol Laboratories, Inc.
Product Contains Dangerous Levels of Endotoxin

The U.S. Food and Drug Administration (FDA) today delivered a letter to Cytosol Laboratories, Inc., of Braintree, Mass., to request a recall of all brands and sizes of Balanced Salt Solution (BSS) that the firm manufactures. BSS is a drug used by health professionals to irrigate a patient's eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery.

FDA requested the recall because product lots were found to have elevated levels of endotoxin. Endotoxins, also known as pyrogens, are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure and in other circulatory functions. FDA has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome(TASS) which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction. FDA has also received complaints relating to injuries in over 300 patients who were given BSS manufactured by Cytosol Laboratories, Inc.

The FDA requests that the company take immediate action to retrieve all inventories of the product, including any existing stock at physician offices and hospitals. An FDA-requested recall is initiated to protect the public health when a product that has been distributed represents a risk of illness or injury and the firm has not initiated a recall of the product. FDA is instructing hospitals, physicians, and consumers to immediately stop using any of these products, quarantine any remaining product, and if no return instructions from Cytosol are received, destroy the product.

An estimated one million units of BSS products were distributed between December 2003 and December 2005. The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:

"AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;
"Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and
"Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.

Individuals with questions may call FDA at 1-888-463-6332. Any adverse reactions or problems experienced with the use of this product should also be reported to the FDA MedWatch Program by completing a form online on the MedWatch web site at www.fda.gov/medwatch/report.htm , by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

AMO Recall release: http://www.eyeworld.org/ewweek.php?i...amo%20recall#2

[Kitchen Witch]

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Flying Salmon, Inc. Issues Alert on Undeclared Soybean in Variety of Tobiko Caviar Repacks

Contact:
Flying Salmon Inc.
1-800-622-8427

FOR IMMEDIATE RELEASE -- San Francisco, CA -- February 14, 2006 -- Flying Salmon Inc. of San Francisco, California is recalling:

* "Carpathian" Brand repacked Japanese Orange Tobiko Caviar in 2oz, 4oz, & 8oz containers
* "Carpathian" Brand repacked Japanese Wasabi Tobiko Caviar in 2oz, 4oz, & 8oz containers
* "Carpathian" Brand repacked Japanese Black Tobiko Caviar in 2oz, 4oz, & 8oz containers

because they may contain undeclared SOYBEAN. People who have an allergy or severe sensitivity to
Soybean run the risk of serious or life-threatening allergic reaction if they consume these products.

The above listed products were distributed in the Northern California area where the products may have been distributed and reached the consumers through retail stores.

The products are packed under the brand name "Carpathian". It may be in 2oz and 4oz plastic or glass jars. The 8oz container is plastic only. The containers in question will not have any ingredient labels attached to its sides.

"No illnesses have been reported to date".

The recall was initiated after FDA inspectors, during a routine inspection, discovered that the variety of the Tobiko Caviar (mentioned above) containing SOYBEAN were distributed in packaging that did not reveal the presence of SOYBEAN. Subsequent investigation indicates the problem was caused by a temporary breakdown in company?s production and packaging processes.

Consumers who have purchased the "The Variety of Tobiko Products" of the "Carpathian" Brand are urged to return the product to the place of purchase for a full refund. Consumers with questions may contact FLYING SALMON, INC. at 1-800-622-8427.

[Kitchen Witch]

Recall -- State Press Release
Consumer Alert: Undeclared Milk in Keikitos (Muffins)

Contact:
Jessica Chittenden
518-457-3136

FOR IMMEDIATE RELEASE -- February 15, 2006 -- State Agriculture Commissioner Patrick H. Brennan today alerted consumers that Marito's Bakery, 521 Union Ave., Westbury, New York 11590 is recalling 8 ounce packages of "Keikitos" (muffins) due to an undeclared milk ingredient. People who have allergies to milk may run the risk of serious or life-threatening allergic reactions if they consume this product.

The recall includes all codes of "Keikitos" (muffins) in 8 ounce plastic bags. It was sold in Long Island, New York, and New Jersey.

The problem was discovered as a result of routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department's Food Laboratory personnel revealed the presence of a milk ingredient in product packages which did not declare a milk ingredient on the label.

No illnesses have been reported to date to this Department in connection with the problem.

Consumers who have purchased "Keikitos" (muffins) should return it to the place of purchase.

[Kitchen Witch]

FDA News

FOR IMMEDIATE RELEASE
P06-24
February 16, 2006

Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

Stronger Warnings for Tequin

Today, Bristol-Myers Squibb Co. announced labeling changes for Tequin (gatifloxacin), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.

The labeling changes, announced by the Tequin manufacturer in a letter to healthcare professionals, update the prescription information as a result of continued reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin. Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes.

Information about the risks of low blood sugar and high blood sugar was added to the WARNINGS section of the U.S. labeling in 2002. Today's changes strengthen the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), add a CONTRAINDICATION for use in diabetic patients, and include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin.

The FDA will continue monitoring Tequin's safety to ensure that its benefits outweigh the risks to patients.