COSEAL Surgical Sealant Kit — Class II medical device recall Z-1838-2016
Terminated recall by Baxter Healthcare Corp, reported 2016-06-08, distributed nationwide. Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of t
| Recall number | Z-1838-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Hayward, CA, United States |
| Recall initiated | 2016-05-12 |
| Classified | 2016-05-31 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS, CA, SG |
| Quantity | 274 units |
| Reason classes | specification failure |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1838-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.