Recall Z-2547-2021 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
| Date | Aug 10, 2021 |
| Status | Terminated |
| Reason | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Root cause | Under Investigation by firm |
| Action | BBraun issued Urgent Medical Device Correction letter to direct end customers and BBMI distributors, dated 8/10/21. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the impacted product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the customer level. 2. Copies of Attachment 02 should be distributed to all personnel and staff |
| Quantity | 1,960 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Canada. |
| FDA record | Open on fda.gov |