Recall Z-1838-2016— Baxter Healthcare Corp
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corp, initiated 2016-05-12, terminated 2017-03-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Baxter Healthcare Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-12
- Terminated
- 2017-03-23
- Firm location
- Hayward, CA, United States
Product description
COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.