Recall Z-0870-04 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Deltec, Inc
Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4085-24
| Date | Jul 20, 2004 (initiated Mar 29, 2004) |
| Status | Terminated |
| Reason | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. |
| Root cause | Other |
| Action | A recall letter dated March 26, 2004 gave customers the option of returning the products or using the products if the customer's procedures do not require sterility of the outer surface of the inner tray. |
| Distribution | The recalled products were shipped nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962695 | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER Sims Deltec, Inc., Oct 1, 1996 |