FDA Medical Device Recalls (openFDA)
Baxter Bioscience: Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
- Recall number
- Z-1948-2010
- Recalling firm
- Baxter Bioscience
- Product
- Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
- Status
- Terminated
- Initiated
- 2010-01-14
- Posted
- 2010-07-02
- Terminated
- 2010-12-22
- Reason
- 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
- 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
- 3,769
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: HA080828, HA080841, HA081101, HA081216, HA081217, HA090113, HA090225, HA090226, & HA090427.
- 510(k) numbers
- not on file
- PMA numbers
- ["P030039"]
- Product code
- NBE
- Firm FEI
- 1417572
- Firm city
- Westlake Village
- Firm state
- CA
- 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