Baxter recalls specific sizes of disposable internal vessel occluders due to inaccurate marketing brochure content that conflicts with product instructions and prescribing information.
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 sizes of disposable internal vessel occluders because marketing brochures contain inaccurate information that doesn't match the product's instructions or prescribing details. This recall affects medical devices used in cardiovascular surgery procedures.
The marketing brochure distributed with these products contains information that does not align with the actual instructions for use or prescribing information. This discrepancy could lead to incorrect usage or misunderstandings about how the device should be applied in medical procedures.
Healthcare professionals and patients using Baxter's Flo-Rester disposable internal vessel occluders in cardiovascular surgery procedures. Those with the specific product codes listed in the recall are most at risk.
Check if your device has a product code listed in the recall (e.g., 50100, 50150, 50175, etc.) with the corresponding size and global measurements. Look for the unique identification numbers (UDI/DI) provided in the recall list.
Identify your device's product code from the list of codes provided in the recall notice.
Compare your device's documentation with the recall list to confirm if it is affected.
The marketing brochure contains inaccurate content that does not align with the product's instructions for use or prescribing information.
Baxter Flo-Rester disposable internal vessel occluders with product codes 50100 through 60450BIOS, including specific sizes and global measurements.
Check if your device has a product code listed in the recall (e.g., 50100, 50150, etc.) and the corresponding unique identification number (UDI/DI) provided in the notice.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0656-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0656-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
