Z-0669-2024 Class II Ongoing
FDA device recall Z-0669-2024 was initiated by Baxter Healthcare Corporation on December 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 fo… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- December 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
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
VG0108N: 0338-9564-02 VG0110N: 0338-9564-03 VG0106N: 0338-9564-04 VG0209N: 0338-9564-05 All serial numbers