Recall Z-1636-2018 ยท OWL Peripheral Catheter Insertion Kit
Vygon U.S.A.
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
| Date | Feb 28, 2018 |
| Status | Terminated |
| Reason | Potential friction holes may affect the sterility of the product. |
| Root cause | Under Investigation by firm |
| Action | 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 in |
| Quantity | 16520 total products |
| Distribution | Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.