COSEAL Surgical Sealant Kit recall: Failed Dissolution
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing…
Why was COSEAL Surgical Sealant Kit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222
- Product
- COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing…
- Recalling firm
- Baxter Healthcare Corp
- Quantity
- 6,128 units
- Distribution
- Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
- Recall date
- June 8, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)