Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
This recall has been terminated (originally issued February 28, 2018).
- Company
- Vygon U.S.A.
- Recall Initiated
- February 28, 2018
- Terminated
- February 19, 2019
- Recall Number
- Z-1634-2018
- Quantity
- 16520 total products
- Firm Location
- Lansdale, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential friction holes may affect the sterility of the product.
Distribution
Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Lot / Code Info
Lot Number: 17C060D UDI: 08498840010563
Root Cause
Under Investigation by firm
Action Taken
The firm, Vygon USA, mailed an "URGENT MEDICAL DEVICE RECALL" letter dated 2/28/2018 to affected customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: 1) Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2) Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form; 3) complete and return form via Fax to 215-672-6740 or email to: customerservice@vygonus.com including customer contact information; 4) Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5) Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. Distributors are instructed to: communicate the recall to customers who received the affected product by providing them a copy of the notification. Also, provide a copy of the Recall Acknowledgement and Inventory Return Form to customers. If you have questions or concerns 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.