Baxter recalls Flo-Thru Intraluminal Shunts with specific product codes due to inaccurate marketing brochures that don't match product instructions. Consumers should check serial numbers and contact Baxter for details.
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).
Baxter is recalling certain Flo-Thru Intraluminal Shunts because marketing brochures contain inaccurate information that doesn't match the product's instructions. This could lead to improper use if healthcare providers rely on the outdated brochure content.
The marketing brochure distributed with these shunts contains information that doesn't match the actual product instructions or prescribing information. This could cause confusion if healthcare providers use the brochure instead of the current instructions, potentially leading to incorrect use during procedures.
Healthcare providers using Baxter Flo-Thru Shunts with the listed product codes are most at risk. Patients using these shunts are generally not affected as they are medical devices used in specific procedures.
Check the product code on the shunt (FT12100 to FT12300) and the serial number (UDI/DI codes starting with 85412532431 to 85412532516). These shunts were sold globally between 2019 and 2023.
Identify the product code on the shunt (FT12100 to FT12300) to determine if it's affected.
Reach out to Baxter Healthcare Corporation for specific guidance on affected units and next steps.
The marketing brochure contains inaccurate content that doesn't align with the product's current instructions or prescribing information.
No, the recall is for information accuracy, not a safety hazard. Healthcare providers should follow current instructions instead of the outdated brochure.
Check the product code (FT12100 to FT12300) and serial number (UDI/DI codes starting with 85412532431 to 85412532516).
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0663-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0663-2024 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
