medical Class II Updated 2024-01-17

Baxter Healthcare Corporation recalls Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes:

Recalled Product

Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All serial numbers a) ADS202105, UDI/DI 85412827957; b) ADS202110, UDI/DI 85412827896
View official government recall

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