Recall Z-1840-2016 ยท NBE Sealant, Polymerizing
Baxter Healthcare Corp
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
| Date | May 31, 2016 (initiated May 12, 2016) |
| Status | Terminated |
| Reason | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Product Recall letter dated 5/13/16 was sent to customers to inform them that Baxter Healthcare Corporation is issuing a voluntary product recall for the product codes and lots listed below due to the potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. The letter provides the customers with the list of affected products, hazards involved, and actions to be taken. Customers with questions regarding the recall communication, are instructed to co |
| Quantity | 6,128 units |
| Distribution | Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.