Z-1614-2012

Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant

Name: Z-1614-2012 Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant
Creator: Baxter Healthcare Services L.P.
Published: 2011-07-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-07-28 / Terminated / root cause: design

FDA source

Baxter Healthcare Services L.P. began a recall of Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant on 2011-07-28. The reason FDA records is "The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal stability study. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1614-2012
Status: Terminated
Initiated: 2011-07-28
Posted: 2012-05-16
Terminated: 2012-05-31
Recalling firm: Baxter Healthcare Corporation
Product: Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.
Product code: NBE Sealant, Polymerizing
Reason for recall: The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal stability study. The parameter that is out specification is an indicator of possible failure for the product to gel appropriately . Coseal's failure to gel does not represent risk for the patient's life
Root cause tag: design
FDA root cause: Device Design
Action: Baxter Healthcare sent an"URGENT PRODUCT RECALL" letter dated July 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop the usage/distribution of the affected product and to quarantine any units that are in inventory. Instructions for obtaining replacement product were attached to the letter. Contact the firm at 1-800-423-2090 for questions concerning this recall.
Quantity in commerce: 11160
Distribution: Nationwide Distribution.
Product codes and lots: Lot numbers: (2mL) HA100143, HA091236. (4mL) HA090950, HA090944, HA090843, HA090749, HA090947. (8mL) HA100132, HA100142

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)