Device product
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Z-1840-2016
Product summary
- Event
- Event 74139
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,128 units
- Official record key
device-enforcement:Z-1840-2016
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: HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222
Distribution pattern: Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
Derived failure modes
-
Unknown
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.