Z-0663-2024 Class II Ongoing
FDA device recall Z-0663-2024 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
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.25 GLOBAL; g) Product Code FT12250, 2.50 GLOBAL; h) Product Code FT12275, 2.75 GLOBAL; i) Product Code FT12300, 3.00 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
All serial numbers, a) Product Code FT12100, UDI/DI 85412532431; b) Product Code FT12125, UDI/DI 85412532448; c) Product Code FT12150, UDI/DI 85412532455; d) Product Code FT12175, UDI/DI 85412532462; e) Product Code FT12200, UDI/DI 85412532479; f) Product Code FT12225, UDI/DI 85412532486; g) Product Code FT12250, UDI/DI 85412532493; h) Product Code FT12275, UDI/DI 85412532509; i) Product Code FT12300, UDI/DI 85412532516