Device product
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Z-0661-2024
Product summary
- Event
- Event 93503
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0661-2024
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: All serial numbers a) ADS201844, UDI/DI 85412639598; b) ADS201845, UDI/DI 85412639604
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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).