Consumer Lawyers

Archive for August, 2012|Monthly archive page

FDA IDs farm in salmonella cantaloupe outbreak

In Uncategorized on August 23, 2012 at 9:47 pm

U.S. health officials have identified Chamberlain Farm Produce Inc. of Owensville, Ind., as one possible source of cantaloupes tied to an outbreak of salmonella food poisoning that now has sickened 178 people in 21 states. Two people have died.

Federal Food and Drug Administration officials warned late Wednesday that consumers should not eat melons from the previously unidentified farm.

http://vitals.nbcnews.com/_news/2012/08/23/13424997-fda-ids-farm-in-salmonella-cantaloupe-outbreak?lite

FDA officials were under pressure from food safety advocates to release the name of the grower that now has voluntarily recalled the rest of this year’s cantaloupe crop because of detection of a strain of salmonella Typhimurium.

The two deaths occurred in Kentucky. Sixty-two people have been hospitalized nationwide after eating salmonella-tainted fruit, officials said.

FDA officials added that the investigation into the outbreak is continuing and that other possible sources could be identified.

Advertisements

Covidien Implements a Voluntary Recall of Certain Lots of Shiley™ Adult Tracheostomy Tubes

In Uncategorized on August 23, 2012 at 3:54 pm

– Covidien  announced that it notified customers on July 18, 2012, about a voluntary global recall of certain lots of its Shiley™ reusable cannula, cuffed adult tracheostomy tubes, size 8. This action was in response to reports of volume leakage and/or disconnection between the inner and outer cannulae.

Customers are instructed to return all Shiley 8LPC and 8FEN tracheostomy tubes from the affected lots. If one of the recalled tubes is already in use in a patient, the Company recommends that the tube be replaced as soon as clinically appropriate as determined by the patient’s physician. If the physician advises leaving the tracheostomy tube in place, the Company strongly encourages that the frequency of direct patient observation be increased.

Only certain lots of the size 8 adult, reusable tracheostomy tubes are included in this product recall. All other sizes and styles of Shiley™ tracheostomy tubes are unaffected by this action.  These tracheostomy tubes were distributed from October 2009 through June 2012.

Worldwide Product Codes

Product Code

Starting
Lot Number

Ending
Lot Number

8FEN

0910000342

1101001558

8FEN

110201893X

120600700X

 

 

 

8LPC

0910000346

1101001823

8LPC

110200327X

120600351X

This voluntary recall was initiated following an analysis by Covidien of customer reports of volume leakage and/or disconnection between the inner and outer cannula involving these specific tracheostomy tubes. These events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. Volume leakage and/or disconnection could impact ventilation.

Covidien has alerted customers by mail of its voluntary recall action and provided instructions on returning the devices. The U.S. Food and Drug Administration and other regulatory bodies have also been notified.

Replacements for the affected lots of product are expected to be available soon. Alternative Covidien products to meet customer needs for the impacted product codes are available.

Adverse reactions experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by phone or fax.

For information or to report a problem, please contact:

  • Covidien Technical Services at (800) 635-5267, option 3, then option 1. Support is available during business hours with emergency service support available after these times.

OTC DRUG Nationwide Recall –Important Information About Benzalkonium Chloride Antiseptic Wipes

In Uncategorized on August 23, 2012 at 3:46 pm

DUKAL Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for DUKAL by Jianerkang Medical Dressing Co. Benzalkonium chloride antiseptic wipes are sold separately over-the counter and in kits.
This recall is being initiated due to concerns about potential microbial contamination with Burkholderia cepacia. All customers are advised to discontinue use of products identified in this recall immediately as their use could lead to infections, some of which pose certain health risks in immune-suppressed patients. For average healthy people, the presence of Burkholderia cepacia on the swab is not likely to cause serious health risks.
To date, there have been no reported incidents involving these products. In an abundance of caution, we are voluntarily recalling these products to prevent any such potential risk. All customers should dispose of the product. All distributors and kit packers, who include benzalkonium chloride swabs or antiseptic wipes as a component in their kits, should discontinue use of the product and initiate a sub-recall to their customers. All distributors and kit packers should return product in their inventories to DUKAL. These products were distributed nationwide to the wholesale and retail levels.
DUKAL is deeply committed to providing high quality, reliable products and issues this recall as a precaution to ensure consumer safety. DUKAL continues to work closely with FDA to ensure our products meet or exceed FDA requirements.

Instructions

This voluntary recall is for the following BZK product lot numbers:

 

Items

Description

Put Up

0204

Zee Antiseptic Swabs, Med 2ply

50/box, 36box/case

0271

Zee Antiseptic Swab, Med 2 ply

100/bx, 20bx/cs

854

Dukal BZK Swab Med. 2 ply NS

1/pch200/bx20bx/cs

02040

Zee Antiseptic Swab, Med 2 ply

50/box 36bx/cs

2633

Zee Antiseptic Swab, Med, 2ply

10/bx,10bx/bdl,6bdl/cs

854-1000

Dukal BZK Swab Med. 2 ply NS

1/pch1000/bx4bx/cs

Items

Lot No.

0204

JT14509

0204

JT15209

0204

JT20609

0204

JT20909

0204

JT23709

0204

JT27809

0204

JT32809

0204

JT00710

0204

JT15810

0204

JT18310

0204

JT18810

0204

JT23210

0204

JT25810

0204

JT27610

0204

JT31510

0204

JT35610

0204

JT35911

0204

JT04811

0204

JT05311

0204

JT11811

0204

JT15211

0204

JT15911

0204

JT18211

0204

JT21511-1

0204

JT26311

0204

JT30711

0204

JT22011-1

0204

JT01012

0204

JT04112

0204

JT06512

0204

JT07512

0271

JT14509

0271

JT15209

0271

JT21409

0271

JT20609

0271

JT22009

0271

JT00710

0271

JT18810

0271

JT23210

0271

JT35911

0271

JT05311

0271

JT11811

0271

JT26311

0271

JT01012

854

JT00610

854

JT14511

854

JT22011

854

JT30711

02040

JT14509

02040

JT15209

02040

JT20609

02040

JT15209

02040

JT23709

02040

JT27809

02040

JT00710

02040

JT18310

02040

JT18810

02040

JT23210

02040

JT27610

02040

JT31510

2633

JT14509

2633

JT15209

2633

JT21209

2633

JT27809

2633

JT12510

2633

JT15810

2633

JT18310

2633

JT11811

2633

JT13211

2633

JT15911

2633

JT35911

2633

JT01012

2633

JT30711

854-1000

JT34808

854-1000

JT08209

854-1000

JT15209

854-1000

JT32809

854-1000

JT00610

854-1000

JT27610

854-1000

JT05311

854-1000

JT08011

854-1000

JT18211

854-1000

JT22711-1

854-1000

JT26411

854-1000

JT01012

854-1000

JT01411

854-1000

JT14611

854-1000

JT29011

854-1000

JT01212