Skip to content

Baxter Bio Science

Country not established

Devices
1
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Baxter Bio Science makes

Baxter Bio Science manufactures the COSEAL Surgical Sealant (Premixed), a premixed biological sealant designed for use in surgical procedures to promote hemostasis and tissue adhesion. This product is intended for applications requiring precise sealing of tissues, such as vascular or abdominal surgeries.

The COSEAL Surgical Sealant (Premixed) is classified as a Class III medical device under FDA regulations and is authorised through a Premarket Approval Application (PMA). The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 5 recalls initiated by Baxter Bio Science, the earliest on 2007-10-25 and the most recent on 2010-01-14. By recorded status: 5 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2010

    • 14 Jan 2010 Z-1948-2010 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide Distribution Submission number: P030039
    • 14 Jan 2010 Z-1949-2010 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide Distribution Submission number: P030039
    • 14 Jan 2010 Z-1950-2010 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide Distribution Submission number: P030039

  • 2008

    • 31 Jul 2008 Z-2340-2008 Unclassified (pre-2012) Terminated The recall is being conducted as a precautionary measure due to potential discoloration of the FloSeal material noted in six (6) non-medical complaints during delivery by the Endoscopic Applicator. Distribution: Nationwide and worldwide to Puerto Rico, Colombia, Hong Kong, New Zealand, Australia, Austria, Belgium, Czech Republic,…
      Full distribution text Nationwide and worldwide to Puerto Rico, Colombia, Hong Kong, New Zealand, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
      Submission number: P990009

  • 2007

    • 25 Oct 2007 Z-0263-2008 Unclassified (pre-2012) Terminated Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid. Distribution: Worldwide-USA, Canada and European Union (France and UK) Submission number: K020666

Frequently asked questions

How many devices does Baxter Bio Science have in the registry?

The registry currently lists 1 device for Baxter Bio Science. Devices recorded under merged duplicate company entries are counted once.

Which registries list Baxter Bio Science's devices?

Among its 1 most recently registered device, Baxter Bio Science has devices listed in FDA PMA (1 device).

What risk classes do Baxter Bio Science's devices fall under?

Among its 1 most recently registered device, the classes recorded for Baxter Bio Science's devices are Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Baxter Bio Science?

FDA recall records list 5 recalls initiated by Baxter Bio Science, the most recent initiated on 14 Jan 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Baxter Bio Science in the registry?

The most recently registered devices listed for Baxter Bio Science include COSEAL SURGICAL SEALANT (PREMIXED).

Generated automatically from registry data and not verified by a human reviewer.