Recall Z-1469-2015 ยท FPA Set, Administration, Intravascular
Churchill Medical Systems, Inc.
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
| Date | Apr 21, 2015 (initiated Jan 15, 2015) |
| Status | Terminated |
| Reason | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Root cause | Process design |
| Action | Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further |
| Quantity | 2350 |
| Distribution | Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL. |
| FDA record | Open on fda.gov |