FDA-Device2016-06-08Class II
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Baxter Healthcare Corp
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.
Sold states
Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
Affected count
6,128 units
Manufactured in
21026 Alexander Ct, N/A, Hayward, CA, United States
Products
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1840-2016Don't want to check this manually?
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