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Recall Observatory FDA recall evidence

Device product

COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Z-1838-2016

May 12, 2016

Class II

Product summary

Firm
Baxter Healthcare Corp
Event
Event 74139
Status
Terminated
Classification
Class II
Quantity
274 units
Official record key
device-enforcement:Z-1838-2016

Official wording

Reason: 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.

Code information: HA160136

Distribution pattern: Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.