Churchill Medical Systems AMS-8431CP (PICC insertion Tray). The device intended use is a PICC insertion tray.
This recall has been terminated (originally issued June 11, 2011).
- Company
- Vygon Corporation
- Recall Initiated
- April 19, 2011
- Posted
- June 11, 2011
- Terminated
- June 18, 2012
- Recall Number
- Z-2390-2011
- Quantity
- 1,500 units
- Firm Location
- Montgomeryville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.
Distribution
United States (FL, MA, MD, and VA).
Lot / Code Info
Lot Number: 10H30.
Root Cause
Nonconforming Material/Component
Action Taken
A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.