Recall Z-0032-04 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Boston Scientific Scimed
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
| Date | Oct 15, 2003 (initiated Aug 20, 2003) |
| Status | Terminated |
| Reason | Some of the recalled catheters have a component that has levels of pyrogens above specification. |
| Root cause | Other |
| Action | Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them. |
| Quantity | 2 catheters |
| Distribution | The recalled products were distributed to consignees located nationwide in the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.