Recall Z-1052-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Boston Scientific Corporation
PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1205221. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY
| Date | Jul 28, 2005 (initiated Mar 5, 2004) |
| Status | Terminated |
| Reason | Lumens may have incorrect lumen size marked on them. |
| Root cause | Other |
| Action | Letters dated March 5, 2004 with instructions to return product to Boston Scientific. |
| Quantity | 44 kits |
| Distribution | Nationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963097 | CLAMPLESS VALVED CATHETER-PICC (CVC-PICC) Bmw Medical, Inc., Oct 18, 1996 |