Recall Z-1105-03 ยท GBR
Boston Scientific Scimed
Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4020
| Date | Aug 12, 2003 (initiated Jul 1, 2003) |
| Status | Terminated |
| Reason | Some of the product pouches have holes in the seals. |
| Root cause | Other |
| Action | Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them. |
| Quantity | 78 |
| Distribution | The recalled products were shipped to hospitals located nationwide in the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021735 | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER Boston Scientific Scimed, Inc., Aug 8, 2002 |