FDAFDA · Food and drugs·Recall number Z-1840-2016
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Published June 8, 2016 · Recall initiated: May 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp
- Distributor
- Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
- Lot
- HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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