PlainRecalls
FDA Devices Moderate Class II Ongoing

Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883

Reported: January 17, 2024 Initiated: December 6, 2023 #Z-0667-2024

Product Description

Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883

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).

Details

Distribution
US Nationwide distribution.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883. Recalled by Baxter Healthcare Corporation.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0667-2024.