Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Safety

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.

 

Churchill Medical Systems, A Vygon Company, Skin-Prep Wipes used in Convenience Kits

 

Contact:
Vygon Customer Service
1-800-473-5414 
 

FOR IMMEDIATE RELEASE - June 1, 2011- Churchill Medical Systems, A Vygon Company, is initiating a nationwide recall of certain lots of 5 hospital-use convenience kits. These products contain Skin-Prep Wipes that were affected by an April 2011 recall initiated by Smith & Nephew due to the potential for bacterial contamination. The Skin-Prep Wipes were manufactured in the same facility as The Triad Group’s affected products. Testing was conducted by Smith & Nephew on product lots distributed and in quarantine and no contamination has been found to date. No injuries have been reported to Vygon as a result; however, Vygon is initiating this recall out of an abundance of caution as use of contaminated Skin-Prep Wipes could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. FDA has been apprised of this action.

The convenience kits were shipped to distributors and hospitals between September 3, 2010 and March 11, 2011. Consumers who have the following product lots of the 5 convenience kits named below should cease use and coordinate the return and replacement of product with Vygon immediately.
 

Product Code

Product Name

Lot Number

AMS-7080CP

Dressing Change Kit

10J29

10J55

11A18

11A47

11B06

AMS-8316CP-1

Central Line Dressing Kit

10I60

10K42

10F87

AMS-8431CP

PICC Insertion Tray

10H30

AMS-9189CP-1

Dressing Change Kit

1006150

 

 

1006149

 

 

1008143

AMS-9189CP

Dressing Change Kit

1003527

Consumers with questions should contact Vygon’s Customer Service Department Monday through Friday from 8:30 am and 6:00 pm Eastern Time at 1-800-473-5414.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 

 
 

 

###

RSS Feed for FDA Recalls Information [what's this?]

Page Last Updated: 02/18/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.