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Baxter Healthcare Corp recalls COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemo
Recalled June 8, 2016 · FDA recall Z-1840-2016 · Baxter Healthcare
Hazard
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. · FDA Class II
Units
6,128 units
Sold at
Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
Description
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.
Product
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Manufacturer(s)
Baxter Healthcare Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →