Recall Z-1277-2025 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Smiths Medical ASD, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
| Date | Mar 18, 2025 (initiated Feb 13, 2025) |
| Status | Open, Classified |
| Reason | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. |
| Root cause | Process control |
| Action | Smiths medical issued an URGENT MEDICAL DEVICE RECALL to its consignees on 02/13/2025 via letter delivered by traceable means. The notice explained the issue, potential risk, and requested the following: Required Actions for Customers 1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Please return all affected product. 3. Inform all potential users of the product in your organization of this notification and complete and return the attached response form to smithsmedical8171@sedgw |
| Quantity | 3 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.