LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured
FDA device recall Z-0256-05 · posted 2004-11-24 · Terminated
Recall details
- Recalling firm
- Horizon Medical Products Inc
- Reason for recall
- The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.
- Action taken
- Consignees were notified by letter on 09/20/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 44 kits
- Distribution
- FL, GA, LA, MD, NJ, OK, TX, VA
- Date initiated
- 2004-09-20
- Date posted
- 2004-11-24
- Date terminated
- 2005-03-01
- Location
- Manchester, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM (K953529) | Strato/Infusaid, Inc. | 1996-01-26 |