Z-0658-2024 Class II Ongoing
FDA device recall Z-0658-2024 was initiated by Baxter Healthcare Corporation on Dec 6, 2023 and is designated Class II. 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… The recall status is ongoing.
Recall details
- Product Type
- Devices
- Report Date
- Jan 17, 2024
- Initiation Date
- Dec 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
Product description
Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
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).
Distribution pattern
US Nationwide distribution.
Code information
All serial numbers, no UDI/DI
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0658-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026