FDA Medical Device Recalls (openFDA)
Baxter Healthcare Services L.P.: Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.
- Recall number
- Z-1614-2012
- Recalling firm
- Baxter Healthcare Services L.P.
- Product
- Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.
- Status
- Terminated
- Initiated
- 2011-07-28
- Posted
- 2012-05-16
- Terminated
- 2012-05-31
- Reason
- 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
- 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
- 11160
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot numbers: (2mL) HA100143, HA091236. (4mL) HA090950, HA090944, HA090843, HA090749, HA090947. (8mL) HA100132, HA100142
- 510(k) numbers
- not on file
- PMA numbers
- ["P030039"]
- Product code
- NBE
- Firm FEI
- 3000121413
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28