Baxter recalls Coseal Premix surgical sealant products with specific codes due to inaccurate marketing brochure content conflicting with product instructions. Affected units may have no UDI/DI 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 three specific surgical sealant products because their marketing brochure contains inaccurate information that doesn't match the product's instructions or prescribing details. This could lead to improper use if healthcare providers rely on the brochure instead of the official guidelines.
The marketing brochure contains information that does not match the product's official instructions or prescribing details. If healthcare providers use the brochure as their primary reference, they might make errors in application that could affect surgical outcomes.
Healthcare providers using Baxter Coseal Premix surgical sealants with product codes 934070, 934071, or 934072 are likely affected. Medical professionals who follow the marketing brochure instead of the product's instructions are at most risk.
Check for product codes 934070, 934071, or 934072 on the packaging. Products with these codes may have no UDI/DI numbers.
Check the product's official instructions for use and prescribing information instead of the marketing brochure.
The marketing brochure contains inaccurate content that does not align with the product's instructions for use or prescribing information.
Product codes 934070, 934071, and 934072.
Products with codes 934070 and 934071 have UDI/DI numbers; code 934072 has no UDI/DI number.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0657-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0657-2024 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.
