Baxter recalls specific 5mL and 10mL hemostatic matrix products due to inaccurate marketing materials conflicting with product instructions.
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 two specific sizes of hemostatic matrix products because their marketing brochure contains information that doesn't match the actual product instructions. This could lead to improper use if someone follows the brochure instead of the correct instructions.
The marketing brochure contains inaccurate information that doesn't align with the product's instructions for use or prescribing information. This could cause confusion about how to properly use the product during surgery.
Healthcare professionals using these products for cardiovascular surgery may be affected. Those who have the specific product codes or serial numbers listed are most at risk.
Check for product codes: ADS201844 (5mL) or ADS201845 (10mL). Look for serial numbers: 85412639598 for 5mL or 85412639604 for 10mL.
Verify your product has the specific codes and serial numbers listed in the recall notice.
The marketing brochure contains inaccurate content that doesn't align with the product's instructions for use or prescribing information.
The recall notice does not specify a remedy, so no action is required beyond checking your product details.
Check for product codes: ADS201844 (5mL) or ADS201845 (10mL) with serial numbers 85412639598 or 85412639604.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0661-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0661-2024 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.
