Recall Z-1614-2012 ยท NBE Sealant, Polymerizing
Baxter Healthcare Services L.P.
Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.
| Date | May 16, 2012 (initiated Jul 28, 2011) |
| Status | Terminated |
| Reason | The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal stability study. The parameter that is out specification is an indicator of possible failure for the product to gel appropriately . Coseal's failure to gel does not represent risk for the patient's life |
| Root cause | Device Design |
| Action | Baxter Healthcare sent an"URGENT PRODUCT RECALL" letter dated July 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop the usage/distribution of the affected product and to quarantine any units that are in inventory. Instructions for obtaining replacement product were attached to the letter. Contact the firm at 1-800-423-2090 for questions concerning this recall. |
| Quantity | 11160 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.