Baxter Healthcare recalls FloSeal Hemostatic Matrix NL 5mL due to inaccurate marketing brochure content conflicting with product instructions. Affected units have specific product codes and serial numbers.
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 FloSeal Hemostatic Matrix NL 5mL products because a marketing brochure contains inaccurate information that doesn't match the product's instructions for use or prescribing information. This could lead to confusion about how to safely use the product during cardiovascular surgery.
The marketing brochure distributed with the product contains information that doesn't match the actual instructions for use or prescribing information. This discrepancy could cause healthcare providers to use the product incorrectly during surgery, potentially leading to complications.
Healthcare professionals using the FloSeal Hemostatic Matrix NL 5mL product for cardiovascular surgery are most at risk. Patients receiving this product during surgery may also be affected if the instructions are misunderstood.
Check for product codes starting with ADS201883 and serial numbers matching UDI/DI 85412656304. The product is a 5mL hemostatic matrix used in cardiovascular surgery.
Verify the product code and serial number against the recall details to confirm if your item is affected.
The recall is due to inaccurate marketing brochure content conflicting with product instructions, not an immediate safety hazard. The product itself is safe when used correctly.
The recall does not require immediate action like stopping use or returning the product. Check the product code and serial number to see if it's affected.
Look for product codes starting with ADS201883 and serial numbers matching UDI/DI 85412656304. The product is a 5mL hemostatic matrix used in cardiovascular surgery.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0667-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0667-2024 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.
