Z-1838-2016Class II

COSEAL Surgical Sealant Kit, 2 mL

Name: Z-1838-2016 COSEAL Surgical Sealant Kit, 2 mL
Creator: Baxter Healthcare Corp
Published: 2016-05-12
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2016-05-12 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp began a recall of COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of... on 2016-05-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1838-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-12
Posted: 2016-05-31
Terminated: 2017-03-23
Recalling firm: Baxter Healthcare Corporation
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.
Product code: NBE Sealant, Polymerizing
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Product Recall letter dated 5/13/16 was sent to customers to inform them that Baxter Healthcare Corporation is issuing a voluntary product recall for the product codes and lots listed below due to the 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. The letter provides the customers with the list of affected products, hazards involved, and actions to be taken. Customers with questions regarding the recall communication, are instructed to contact Baxter Product Surveillance at (800) 437-5176, 8-5pm, Monday-Friday.
Quantity in commerce: 274 units
Distribution: Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
Product codes and lots: HA160136

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1838-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1838-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1839-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1840-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code NBE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)