Baxter recalls Preveleak Surgical Sealant due to inaccurate marketing brochure content conflicting with product instructions. Affected units include 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 its Preveleak Surgical Sealant product 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 sealant during cardiovascular surgery.
The marketing brochure contains information that doesn't match the actual product instructions or prescribing details. This discrepancy could cause confusion during surgical procedures, potentially affecting the safe use of the sealant.
Surgical teams and hospitals that use Baxter Preveleak Surgical Sealant for cardiovascular procedures are likely affected. Patients undergoing surgery with this product may be at risk if the instructions are misunderstood.
Check for product codes ADS201808 or serial numbers starting with 5413765583582 on the sealant packaging. The recall covers all units with these identifiers.
Review the product code and serial number on the sealant packaging to confirm if it matches the recalled items (ADS201808 or serial numbers starting with 5413765583582).
The recall is due to inaccurate marketing brochure content that doesn't align with product instructions, but the product itself is not considered dangerous in normal use.
Check for product code ADS201808 or serial numbers starting with 5413765583582 on the sealant packaging.
The recall does not require immediate action; check the product information to confirm if it's affected.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0660-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0660-2024 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.
