Recall Z-1509-2021 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
| Date | Mar 15, 2021 |
| Status | Terminated |
| Reason | BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime. |
| Root cause | Under Investigation by firm |
| Action | On 03/12/2021, B. Braun issued an Urgent Medical Device Recall notice via letter notifying customers of the potential for the extension set to become occluded or unable to prime. |
| Quantity | 1,900 units |
| Distribution | US Nationwide distribution in the states of NC, CA. |
| FDA record | Open on fda.gov |