COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Reported: June 8, 2016 Initiated: May 12, 2016 #Z-1839-2016
Product Description
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Reason for Recall
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.
Details
- Recalling Firm
- Baxter Healthcare Corp
- Units Affected
- 6,804 units
- Distribution
- Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
- Location
- Hayward, CA
Frequently Asked Questions
What product 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.. Recalled by Baxter Healthcare Corp. Units affected: 6,804 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1839-2016.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11