Recall Z-0711-03 ยท MAF Stent, Coronary
Boston Scientific Scimed
Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
| Date | Apr 9, 2003 (initiated Mar 20, 2003) |
| Status | Terminated |
| Reason | The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility. |
| Root cause | Other |
| Action | Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot and return them. |
| Quantity | 31 stents |
| Distribution | The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.