Recall Z-1950-2010 ยท NBE Sealant, Polymerizing
Baxter Bioscience
Coseal Surgical Sealant 8mL, Product Codes: 934072 & 934075. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
| Date | Jul 2, 2010 (initiated Jan 14, 2010) |
| Status | Terminated |
| Reason | The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a Coseal Stability study. The parameter that is out of specification is an indicator of possible failure for the product to gel appropriately. |
| Root cause | Process control |
| Action | The recall notification was initiated on January 14, 2010 with the firm sending a Product Recall letter and attached Customer Reply Form to the affected consignees. The recall letter informed the consignees of the reason for recall and requested them to immediately stop the usage/distribution of the lots noted above and to quarantine any units you may still have in your inventory. The letter provided instruction for product return. The letter also requested the consignees to please forward the recall information as appropriate to other services/facilities/departments that they may have provi |
| Quantity | 7,409 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.