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U.S. Department of Health and Human Services

Medical Devices

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Churchill Medical Systems, a Vygon Company, Skin-Prep Wipes Used in Convenience Kits and Tray

Recall Class: Class I

Date Recall Initiated: April 19, 2011

Products: Skin-prep wipesfor inclusion into dressing kits and Peripherally- Inserted Central Catheter (PICC) insertion tray.

Product Name Product Code Lot Number
Dressing Change Kit AMS-7080CP 10J29, 10J55, 11A18, 11A47, 11B06
Central Line Dressing Kit AMS-8316CP-1 10I60, 10K42, 10F87
PICC Insertion Tray AMS-8431CP 10H30
Dressing Change Kit AMS-9189CP-1 1006150, 1006149, 1008143
Dressing Change Kit AMS-9189CP 1003527

These products were distributed from September 3, 2010 through March 11, 2011.

Use:

  • Dressing Change Kit is intended for use during a dressing change of a patient with a central line catheter.
  • Central Line Dressing Kit is intended for use as a dressing following the placement of a central line catheter.
  • PICC Insertion Tray is intended for use during the placement of a peripherally inserted central catheter line.

Recalling Firm:

Churchill Medical Systems, a Vygon Company
103 A Park Drive
Montgomeryville, Pennsylvania 18936-9613

Manufacturer:

H&P Industries, doing business as, Triad Group
700 West North Shore Drive
Harland, Wisconsin 53029-8358

Reason for Recall:

The skin-prep wipes were recalled by the manufacturer due to the potential for bacterial contamination. Surgical patients, and patients who are immuno-compromised, such as those with diabetes, cancer, and certain other chronic diseases, may be at potential risk for infection. This may cause serious adverse health consequences or death.

Public Contact:

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

FDA District: New England

FDA Comments:

Customers and Distributors:

Vygon sent a customized letter to their customers by overnight mail. Each customer received the specific product codes and lots that were shipped to them (as described in the Recall Acknowledgement and Inventory Return Form). Distributors were provided with instructions on how to handle the product that was further distributed by them.

On May 31, 2011, the firm issued an updated Recall Notice to two “consignees” affected by the expanded recall.

Consumers:

STOP using the product. Coordinate the return and replacement of the product with Vygon immediately.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.

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