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

Date of Recall

2011-06-03

Recall Details

- 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.

• Online: www.fda.gov/medwatch/report.htm¹
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm².
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

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