FDA-Device2024-01-17Class II
Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
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 Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0658-2024More Baxter Healthcare Corporation recalls
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