COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
FDA Recall Z-1838-2016 · Posted 2016-05-31
Recalling FirmBaxter Healthcare Corp
Recall StatusTerminated
Product CodeNBE
Date Initiated2016-05-12
Date Terminated2017-03-23
Product Quantity274 units
Reason for Recall
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.
Firm 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 contact Baxter Product Surveillance at (800) 437-5176, 8-5pm, Monday-Friday.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.