Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0667-2024

December 06, 2023

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 93503
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0667-2024

Official wording

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).

Code information: UDI/DI 85412656304, All serial numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).