Z-1949-2010

Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in vascular reconstructions to...

Name: Z-1949-2010 Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in vascular reconstructions to...
Creator: Baxter Bioscience
Published: 2010-01-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2010-01-14 / Terminated / root cause: manufacturing process

FDA source

Baxter Bioscience began a recall of Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis on 2010-01-14. The reason FDA records is "The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol...". 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-1949-2010
Status: Terminated
Initiated: 2010-01-14
Posted: 2010-07-02
Terminated: 2010-12-22
Recalling firm: Baxter Healthcare Corporation
Product: Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
Product code: NBE Sealant, Polymerizing
Reason for recall: The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a Coseal Stability study. The parameter that is out of specification is an indicator of possible failure for the product to gel appropriately.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recall notification was initiated on January 14, 2010 with the firm sending a Product Recall letter and attached Customer Reply Form to the affected consignees. The recall letter informed the consignees of the reason for recall and requested them to immediately stop the usage/distribution of the lots noted above and to quarantine any units you may still have in your inventory. The letter provided instruction for product return. The letter also requested the consignees to please forward the recall information as appropriate to other services/facilities/departments that they may have provided this product to. Consignees were instructed to complete the Customer Reply Form, and fax it as soon as possible to 888-345-4261. Consignees with questions were instructed to contact Stericycle at 877-870-4486.
Quantity in commerce: 15,262
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: HA080942, HA080943, HA081001E, HA081046E, HA081102, HA081132, HA081235, HA090139, HA090241, & HA090342.

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)