Thread: F.D.A. Recalls July 2009 - UPDATED DAILY

Recall

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.

Dräger Initiates a Voluntary Device Recall of Stabilet Contacts Current Users

Contact:
Glenyce Scott-Hoglund
215-660-2310
Glenyce.scott@draeger.com

FOR IMMEDIATE RELEASE - Telford, PA – July 20, 2009 - Draeger Medical Inc. recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service and replacing them with alternative warmers as soon as it is feasible.

This action is in response to an event that took place in a neonatal unit of a hospital in Minnesota in 2008. ECRI conducted an investigation of the event and concluded that the likely cause was the Stabilet. Dräger has not been given the opportunity to investigate this incident or to test the Stabilet at issue, and therefore; we cannot comment on ECRI’s investigative conclusions. However, Dräger determined to err on the side of caution and has initiated a voluntary recall. As part of this recall, Dräger agrees with ECRI’s recommendation to remove the Stabilets from service as soon as it is feasible. The recall recommends that the hospital take the following actions:

(1) Hospitals should immediately begin planning to remove the referenced models from service:

a.Hospitals with sufficient number of unaffected models to meet anticipated clinical needs should immediately remove the referenced warmers from service.
b.Hospitals currently unable to provide required heating therapy if these units are removed from service should
i.Begin budgeting for the replacement of the units; and
ii.Limit use of the referenced models to patients NOT requiring O2 – enrichment may increase the risk of fire. Hospitals should inform all potential users of this restriction and clearly mark referenced units to reinforce this message.
iii.Use a different heating modality (e.g., an infant incubator) if an infant requires O2therapy (whether supplemental or via intubation) and no unaffected warmers are available.
(2) Once removed from service, the warmers should be rendered unusable by removing the heating element and the power cord. These warmers should not be used or sold for any other purpose.

In 2004, Dräger acquired from Hill-Rom Co., Inc. (the manufacturer of this product) the Stabilet product line of radiant infant warmers. Hill-Rom discontinued manufacturing the Stabilet product line in 1998, six years prior to its sale to Dräger. Service support and spare parts for Stabilets were discontinued at the end of 2003. All known users of this product line were informed that this product was discontinued at this time.

If you need further information please contact Mike Kelhart (1-800-543-5047 ext 2349). A recall notification is being sent out to all known current users and is available in the Dräger website at www.draeger.com/Stabilet.

Page Last Updated: 07/20/2009
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Recall

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.

Dräger Initiates a Voluntary Device Recall of Stabilet Contacts Current Users

Contact:
Glenyce Scott-Hoglund
215-660-2310
Glenyce.scott@draeger.com

FOR IMMEDIATE RELEASE - Telford, PA – July 20, 2009 - Draeger Medical Inc. recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service and replacing them with alternative warmers as soon as it is feasible.

This action is in response to an event that took place in a neonatal unit of a hospital in Minnesota in 2008. ECRI conducted an investigation of the event and concluded that the likely cause was the Stabilet. Dräger has not been given the opportunity to investigate this incident or to test the Stabilet at issue, and therefore; we cannot comment on ECRI’s investigative conclusions. However, Dräger determined to err on the side of caution and has initiated a voluntary recall. As part of this recall, Dräger agrees with ECRI’s recommendation to remove the Stabilets from service as soon as it is feasible. The recall recommends that the hospital take the following actions:

(1) Hospitals should immediately begin planning to remove the referenced models from service:

a.Hospitals with sufficient number of unaffected models to meet anticipated clinical needs should immediately remove the referenced warmers from service.
b.Hospitals currently unable to provide required heating therapy if these units are removed from service should
i.Begin budgeting for the replacement of the units; and
ii.Limit use of the referenced models to patients NOT requiring O2 – enrichment may increase the risk of fire. Hospitals should inform all potential users of this restriction and clearly mark referenced units to reinforce this message.
iii.Use a different heating modality (e.g., an infant incubator) if an infant requires O2therapy (whether supplemental or via intubation) and no unaffected warmers are available.
(2) Once removed from service, the warmers should be rendered unusable by removing the heating element and the power cord. These warmers should not be used or sold for any other purpose.

In 2004, Dräger acquired from Hill-Rom Co., Inc. (the manufacturer of this product) the Stabilet product line of radiant infant warmers. Hill-Rom discontinued manufacturing the Stabilet product line in 1998, six years prior to its sale to Dräger. Service support and spare parts for Stabilets were discontinued at the end of 2003. All known users of this product line were informed that this product was discontinued at this time.

If you need further information please contact Mike Kelhart (1-800-543-5047 ext 2349). A recall notification is being sent out to all known current users and is available in the Dräger website at www.draeger.com/Stabilet.

Page Last Updated: 07/20/2009
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Recall

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.

Wirth's Nutcracker Sweet Initiates Voluntary Recall Of Pistachios Sold In Michigan Because Of Possible Risk To Health

Contact: Mike Wirth
(989) 687-7400

FOR IMMEDIATE RELEASE-- Sanford, MI –June 16, 2009— Wirth's Nutcracker Sweet of Sanford, MI is voluntarily recalling 258 of their 2-lb holiday party trays containing roasted and salted pistachios in the shell because they have the potential to be contaminated with salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The party trays were distributed for fundraising by Kiwanis Clubs in Michigan (Alma, Bay City, Midland and Saginaw) and were shipped in November and December 2008.

The recalled pistachios were packaged as part of a 2-lb party tray, which also contains cashews, deluxe mixed nuts, chocolate covered peanut clusters and pecan caramel candy. The 2-lb party tray is a round, clear plastic, 6-compartment container with pistachios in one of the compartments. The tray label states Wirth's Nutcracker Sweets and 2 pounds – there is no product name or UPC code on the tray. None of the other products in the tray are affected by the problem.

Albanese Confectionery Group, Inc. notified Wirth's that the pistachios are being recalled because they were purchased from Setton Pistachio of Terra Bella, Inc., who voluntarily recalled them due to possible contamination with salmonella.

Wirth's Nutcracker Sweet has received no complaints or reports of any illness related to this product, or any other products.

Consumers who have purchased the recalled product should either destroy the product or contact the company at (989) 687-7400, from Monday through Friday, 9 a.m. until 4 p.m., to arrange for the return of the product. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s website @http://www.cdc.gov.

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Wirth's Nutcracker Sweet Initiates Voluntary Recall Of Pistachios Sold In Michigan Because Of Possible Risk To Health

Contact: Mike Wirth
(989) 687-7400

FOR IMMEDIATE RELEASE-- Sanford, MI –June 16, 2009— Wirth's Nutcracker Sweet of Sanford, MI is voluntarily recalling 258 of their 2-lb holiday party trays containing roasted and salted pistachios in the shell because they have the potential to be contaminated with salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The party trays were distributed for fundraising by Kiwanis Clubs in Michigan (Alma, Bay City, Midland and Saginaw) and were shipped in November and December 2008.

The recalled pistachios were packaged as part of a 2-lb party tray, which also contains cashews, deluxe mixed nuts, chocolate covered peanut clusters and pecan caramel candy. The 2-lb party tray is a round, clear plastic, 6-compartment container with pistachios in one of the compartments. The tray label states Wirth's Nutcracker Sweets and 2 pounds – there is no product name or UPC code on the tray. None of the other products in the tray are affected by the problem.

Albanese Confectionery Group, Inc. notified Wirth's that the pistachios are being recalled because they were purchased from Setton Pistachio of Terra Bella, Inc., who voluntarily recalled them due to possible contamination with salmonella.

Wirth's Nutcracker Sweet has received no complaints or reports of any illness related to this product, or any other products.

Consumers who have purchased the recalled product should either destroy the product or contact the company at (989) 687-7400, from Monday through Friday, 9 a.m. until 4 p.m., to arrange for the return of the product. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s website @http://www.cdc.gov.

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Recall

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.

Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover

Contact:
Celeste Industries Corporation
410-822-6200, ext 1349

FOR IMMEDIATE RELEASE -- Easton, Maryland – January 5, 2009 – Celeste Industries Corporation has voluntarily recalled all lots of simplySmart™ "Remove" Make Up Remover in the US and Canada This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.

The organism Pseudomonas aeruginosa may cause serious eye infections, respiratory infections, dermatitis, soft tissue infections, bacteremia, and a variety of systemic infections, particularly in patients who are immunosuppressed. Because the Make-Up Remover may be used in the area of the eye, there is a possibility that inadvertent introduction of the tainted product directly in the eye could result in serious eye infections.

No illnesses have been reported to date in connection with this problem. The issue was discovered after a consumer complained of an odor coming from the towelette packets.

This product is not sold in the retail market but is provided as a guest amenity at Holiday Inn Express® hotels in the United States in Canada.

Celeste Industries ceased production of the product on October 5, 2008 and subsequently notified the distributor and the Food and Drug Administration

Any hotel guests who may have taken the product are advised to not use the product and to destroy it immediately. Consumers who have used the product and have any concerns should contact a healthcare professional.

Celeste Industries has identified the source of the contamination and will take all necessary steps to prevent future contamination when production of the product is resumed.

Consumers with questions regarding the recall should contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST and ask for Quality Assurance or e-mail at recall@celestecorp.com. This recall is being made in cooperation with the Food and Drug Administration.

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Recall

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.

Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover

Contact:
Celeste Industries Corporation
410-822-6200, ext 1349

FOR IMMEDIATE RELEASE -- Easton, Maryland – January 5, 2009 – Celeste Industries Corporation has voluntarily recalled all lots of simplySmart™ "Remove" Make Up Remover in the US and Canada This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.

The organism Pseudomonas aeruginosa may cause serious eye infections, respiratory infections, dermatitis, soft tissue infections, bacteremia, and a variety of systemic infections, particularly in patients who are immunosuppressed. Because the Make-Up Remover may be used in the area of the eye, there is a possibility that inadvertent introduction of the tainted product directly in the eye could result in serious eye infections.

No illnesses have been reported to date in connection with this problem. The issue was discovered after a consumer complained of an odor coming from the towelette packets.

This product is not sold in the retail market but is provided as a guest amenity at Holiday Inn Express® hotels in the United States in Canada.

Celeste Industries ceased production of the product on October 5, 2008 and subsequently notified the distributor and the Food and Drug Administration

Any hotel guests who may have taken the product are advised to not use the product and to destroy it immediately. Consumers who have used the product and have any concerns should contact a healthcare professional.

Celeste Industries has identified the source of the contamination and will take all necessary steps to prevent future contamination when production of the product is resumed.

Consumers with questions regarding the recall should contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST and ask for Quality Assurance or e-mail at recall@celestecorp.com. This recall is being made in cooperation with the Food and Drug Administration.

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FDA NEWS RELEASE
For Immediate Release: July 22, 2009

Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA and Public Health Experts Warn About Electronic Cigarettes

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Electronic cigarettes, also called “e-cigarettes,â€

Recall

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.

Tanimura & Antle Voluntarily Recalls One Lot of Romaine Lettuce Because of Possible Health Risk

Company Contact:
Amy Philpott; aphilpott@watsonmulhern.com
202-384-1840

Lisa Watson; lwatson@watsonmulhern.com
202-251-0012

FOR IMMEDIATE RELEASE – July 21, 2009 – Tanimura & Antle, Inc. of Salinas, Calif. is voluntarily recalling one lot of romaine lettuce because it has the potential to be contaminated with Salmonella. No illnesses have been reported to date, and the company is working with FDA to inform consumers of this recall.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recall comes after a random test conducted by the Wisconsin Department of Agriculture tested positive.

Within hours of being notified yesterday, Tanimura & Antle, Inc. traced back the entire lot of romaine and advised all customers who received the recalled product of the test result. Tanimura & Antle, Inc. has instructed these customers to destroy the product. Although the recalled product is past its shelf life, the company is issuing this voluntary recall out of an abundance of caution to ensure that any product purchased by consumers will also be destroyed. Consumers who have purchased the recalled romaine as described above should not consume it, and should destroy the product.

The cartons of bulk or wrapped romaine being recalled are marked with the lot code 531380 and were harvested June 25 - July 2. This recall includes only this single lot of romaine; no other products are involved.

The recalled romaine was sold to retail, wholesale and food service outlets in Canada, Puerto Rico and the following 29 states: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Texas, Massachusetts, Louisiana, Pennsylvania, Tennessee, North Carolina, Michigan, Missouri, Nebraska, New Hampshire, New Mexico, Nevada, Ohio, Oregon, Utah, Virginia, Wisconsin, and Wyoming.

"Tanimura & Antle is committed to our customers and the shoppers who buy our products every day. We practice strict food safety guidelines, using technology and scientific information to ensure that our products are as safe as possible. We will continue to review opportunities for improvement," said Rick Antle, CEO. "Although the recalled product is well beyond the 14-16 day shelf life, we are voluntarily issuing this recall because we want to ensure that we minimize even the slightest risk to public health."

Consumers with questions or who need information may call Tanimura & Antle at 1-877-827-7388 or may visit our web site for updates, www.taproduce.com.

Page Last Updated: 07/27/2009
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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.

Publix Issues Voluntary Recall on Publix Gourmet Peanut Mix Because of Possible Health Risk

Contact:
Maria Brous
863-680-5339

FOR IMMEDIATE RELEASE -- LAKELAND, Fla., Feb. 4, 2009 — Publix Super Markets is issuing a voluntary recall for Publix Gourmet Peanut Mix. The product contains peanut products that are from Peanut Corporation of America, which has been implicated in a national outbreak of Salmonella. Product was distributed to Publix stores for retail sale. The recalled product has a UPC number of: 41415 - 06786 and is packaged in a 28 ounce plastic tamper resistant container.

"As part of our commitment to food safety and in cooperation with the FDA, we are issuing this voluntarily recall," said Maria Brous, Publix director of media and community relations. "Publix stores discontinued the sale of this item prior to the recall; however, since some customers may still have the peanut mix in their homes, we wanted to take every precaution. To date, there have been no reported cases of illness. Consumers who have purchased the product in question may return the product to their local store for a full refund. Publix customers with additional questions may call our Consumer Relations department at 1-800-242-1227 or by visiting our website at www.publix.com."

Page Last Updated: 07/27/2009
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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.

Fireside Coffee Co. Recalls Chai Tea Affected by Plainview Milk Product Recall

Contact:
Angie Root, 800-344-5282
Fireside Coffee Company, Inc.
3239 Elms Rd.
Swartz Creek, MI 48473

FOR IMMEDIATE RELEASE - July 27, 2009 - Fireside Coffee Co. Swartz Creek, MI is recalling all Fireside Chai Tea that contains dry milk produced by Plainview Milk Products after June 2007. Plainview Milk Products of Plainview, MN has recalled its instant non-fat dry milk because of potential Salmonella contamination. No illnesses have been reported to date in connection with this problem.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The Fireside Coffee Co. Chai Tea affected by this recall was distributed nationwide in retail stores, through mail orders and at art fairs. The Chai tea under recall comes in the following four flavors: Spiced, Chocolate, Vanilla and Decaf Vanilla. All four flavors come in a variety of package sizes including a 12oz. box, a 1 lb. sampling bag, 5 lb. bulk packages and single serving packets. The lot number is printed on the bag for each package size and only the following lot numbers are included:

VANILLA CHAI
1LB SAMPLING BAG: D81732157/58/33
12OZ BOX: (UPC: 7-61167-60522-3) A82432157,B827I32156/57, D80932156/57, E8022133/58/32, J831VCHAI32155, L804VCHAI32154, A916VCHAI32216
5LB BAG: C81432158, D81732157/58/33, J831VCHAI32155, A929VCHAI32216
SINGLE SERVE PACKET: (UPC: 7-61167-30522-2) 8311/31255, 8312/31255/35, 8312/31255/3

DECAF VANILLA CHAI ,
12OZ BOX: (UPC: 7-61167-61508-6) A916DVCH32215
SINGLE SERVE PACKET: (UPC: 7-61167-31508-5) 8311/32129/205

CHOCOLATE CHAI
1LB SAMPLING BAG: A83132163/37/38, B801I32137/63/38, D83032141/40, A930CHOCOCHAI32160
12OZ BOX: (UPC: 7-61167-60523-0) A80432162, A81132141/62, A82432137/63, A83132163/37/38, D80932138/63, D82432162/63/38/41, J830CHOCOCHAI32209/139, K812CHOCOCHAI32209/161, L804CHOCOCHAI32160, B917CHOCOCHAI32160/59
5LB BAG: A82432137/63, J814CHOCOCHAI32159, K812CHOCOCHAI32209/161, A929CHOCOCHAI32160
SINGLE SERVE PACKET: (UPC: 7-61167-30523-9) 8215/32209/08

SPICED CHAI
1LB SAMPLING BAG: L70432148/49, B80632148/52/53, D81132150, D83032145, A930SPICEDCHAI32219
12OZ BOX: (UPC: 7-61167-60524-7) A80332147, A81132148, A82432148/47, B80632148/52/53, B80832152/51, B81332151, D81032151/50, J824SPICEDCHAI32207, J830SPICEDCHAI32207/06, J831SPICEDCHAI32206, K810SPICEDCHAI32146/207, K811SPICEDCHAI32146/47/207, K819SPICEDCHAI32147, A908SPICEDCHAI32220
5LB BAG: K72732149, A80732149, A82432148/47, B80632148/52/53, F81932147, K811SPICEDCHAI32146/47/207, A908SPICEDCHAI32220
SINGLE SERVE PACKET: (UPC: 7-61167-30524-6)8312/32206

Consumers who have purchased Fireside Chai Tea with one of the lot numbers listed above should not consume the product and may call 800-344-5282 (M-F from 9:30 a.m. until 4:30 p.m.) to discuss how to return the recalled tea.

Page Last Updated: 07/28/2009
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