Baxter Healthcare Corporation Recall 93503
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
Baxter Healthcare Corporation Recall 93503 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0663-2024 |
| Event ID | 93503 |
| Event 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 Type | Devices |
| Distribution | US Nationwide distribution. |
| Recall 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). |
| Device Classification | 20240117 |
| Device Code Info | 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 |
| Center Classification Date | 20240105 |
| Recall Initiation Date | 20231206 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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