Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-0663-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 6, 2023

Date Posted: January 17, 2024

Recall Number: Z-0663-2024

Event ID: 93503

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).

Status: Ongoing

Product Quantity:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated