FDA Device recall Z-1840-2016
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072 by Baxter Healthcare, citing potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formatio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1840-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-12 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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.
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.
Identifiers
| code_info | HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1840-2016%22
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