Recall Z-0090-06 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Vygon Corporation
Premicath 28G PICC Catheter
| Date | Oct 28, 2005 (initiated Jun 27, 2005) |
| Status | Terminated |
| Reason | Guidewire protuding from tip of the catheter |
| Root cause | Other |
| Action | The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation. |
| Quantity | 243 units |
| Distribution | The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041468 | PREMICATH, 1261.205 Vygon Corp., Sep 9, 2004 |