Recall Z-0256-05 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Horizon Medical Products Inc
LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Book
| Date | Nov 24, 2004 (initiated Sep 20, 2004) |
| Status | Terminated |
| Reason | The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer. |
| Root cause | Other |
| Action | Consignees were notified by letter on 09/20/2004. |
| Quantity | 44 kits |
| Distribution | FL, GA, LA, MD, NJ, OK, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953529 | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM Strato/Infusaid, Inc., Jan 26, 1996 |