Recall Z-0120-2010 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
| Date | Nov 24, 2009 (initiated Oct 21, 2009) |
| Status | Terminated |
| Reason | Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces. |
| Root cause | Component design/selection |
| Action | An "Urgent Medical Device Correction" letter dated October 22, 2009 was issued to the direct accounts. The letter described the problem and actions for consignees. Consignees were instructed to cease distribution of the recalled product and to notify their subaccounts of the problem. In addition, customers were instructed to return the affected, unused product to Thomas Medical Product, Inc.'s contract warehouse, Inner-Space Warehouse, Inc. Contact your local sales representative for questions about the recall, or Customer Service by calling 1-866-446-3003, Monday through Friday from 8:30 |
| Quantity | 17,236 units |
| Distribution | United States (FL and MN). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083269 | CROSSOVER Thomas Medical Products, Inc., Feb 3, 2009 |