Recall Z-0661-2024— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-12-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL. Reason: 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)..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-06
- Firm location
- Deerfield, IL, United States
Product description
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.