Recall Z-1995-2021 ยท FPA Set, Administration, Intravascular
CAREFUSION
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
| Date | Jun 9, 2021 |
| Status | Terminated |
| Reason | A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage. |
| Root cause | Under Investigation by firm |
| Action | On 06/09/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via email and FedEx to customers informing them that a validation lot was inadvertently released to the US market. This product did not meet the validation testing criteria regarding leakage. Potential health consequences associated with the use of the non-validated product is under-infusion. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and lot numbers listed. Destroy all product subject to the recall following their institutions process for destruction. T |
| Quantity | 100 units |
| Distribution | U.S.: TN O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.