FDA-Device2024-01-17Class II
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
Baxter Healthcare Corporation
Hazard
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Sold states
US Nationwide distribution.
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0662-2024Don't want to check this manually?
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