Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COSEAL Surgical Sealant Kit Recalled by Baxter Healthcare Corp Due to Potential for incomplete dissolution of the polyethylene glycol...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corp directly.
Affected Products
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Quantity: 6,804 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corp
Baxter Healthcare Corp has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report