Recall Z-2528-2025 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
B.Braun Medical S.A.S.
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
| Date | Sep 5, 2025 (initiated Jul 21, 2025) |
| Status | Open, Classified |
| Reason | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. |
| Root cause | Under Investigation by firm |
| Action | On July 21, 2025 URGENT - FIELD SAFETY NOTICE - PRODUCT RECALL letters were sent to customers. Actions to be taken: Check whether you have the above-mentioned product in stock, and quarantine it. Confirm the receipt of this Field Safety Notice on the enclosed confirmation form. Additionally record on the enclosed confirmation form the received amount of potentially affected products with the above-mentioned batch number(s) as well as the amount used and the amount to be returned. Even if you don't have any inventory, please return the completed and signed confirmation form in a timely manner t |
| Quantity | 58 units |
| Distribution | US Nationwide distribution in the state of PA. |
| FDA record | Open on fda.gov |