COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Reported: June 8, 2016 Initiated: May 12, 2016 #Z-1840-2016
Product Description
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; 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
- 6,128 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, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.. Recalled by Baxter Healthcare Corp. Units affected: 6,128 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-1840-2016.
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