Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1839-2016 — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

U.S. FDA — Device Enforcement · United States · 2016-05-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1839-2016
Date of alert: 2016-05-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Baxter Healthcare Corp
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1839-2016 — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

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