Baxter Healthcare Corp recalls COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemo…

Recall date

May 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1839-2016

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp

Sold / distributed

Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.