Recall Z-0828-2007 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Integra LifeSciences Corp.
EnDura No-React Dural Substitute 4 cm X 4 cm.
| Date | May 24, 2007 (initiated May 4, 2007) |
| Status | Terminated |
| Reason | Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t |
| Root cause | Other |
| Action | On May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product. |
| Quantity | 12,736 for all recalls Z-0827-0832-2007 |
| Distribution | Nationwide Distribution to hospitals and medical centers |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.