Recall Z-0680-2018 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
| Date | Jul 24, 2017 |
| Status | Terminated |
| Reason | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product. |
| Root cause | Under Investigation by firm |
| Action | Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter. |
| Quantity | 300 units |
| Distribution | U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954302 | VYGON PREMI-CATH - LONG TERM CATHETER Vygon Corp., Jun 17, 1996 |