Recall Z-0442-05 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Smiths Medical MD, Inc.
Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6 mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introducer Set. Immediate package states Contents of unopened and undamaged individual product packages are STERILE and non-pyrogenic. Check package integrity before use. Destroy after use. Do not rester
| Date | Jan 28, 2005 (initiated Nov 11, 2004) |
| Status | Terminated |
| Reason | The catheter became disconnected from the port while implanted in the patient. |
| Root cause | Other |
| Action | USA consignees were contacted by telephone on 11/11/04. The international consignees were e-mailed and telephone contacted on 11/11/04. The Customer Recall Notification Letter was mailed or faxed on 11/16/04. Customers were asked to inspect their inventory for the affected recall lot and then requested to return any unused product to Smiths Medical. As a result of the recall, some customers may be affected by product unavailability. Smiths'' is endeavoring to have product available as soon as possible. For implanted product it is essential to confirm portal and catheter integrity as desc |
| Quantity | 75 trays |
| Distribution | To 11 facilities in FL, GA, ME, MN, NH, NJ, OK, TX, WI, WV and Peurto Rico. And to 2 international distributors (Canada and Taiwan). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM Pharmacia Deltec, Inc., Jul 26, 1994 |