Baxter Healthcare recalls Ostene Hemostasis Materials with specific product codes due to inaccurate marketing brochure content 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 Healthcare is recalling three specific sizes of Ostene Hemostasis Materials because their marketing brochure contains inaccurate information that doesn't match the product's instructions. This could lead to improper use during cardiovascular surgery.
The marketing brochure contains information that doesn't match the actual product instructions or prescribing information. This discrepancy could lead to incorrect usage during cardiovascular surgery procedures.
Surgical teams and hospitals that use these specific product codes for cardiovascular procedures are most at risk. Patients undergoing surgery with these materials may be affected if the instructions are misinterpreted.
Check for product codes 1503831 (3.5 G), 1503832 (2.5 G), or 1503833 (1.0 G) on the packaging. These materials were sold without unique device identifiers (UDI/DI).
Identify if your Ostene Hemostasis Material has one of the product codes: 1503831 (3.5 G), 1503832 (2.5 G), or 1503833 (1.0 G).
The marketing brochure contains inaccurate content that does not align with the product's Instructions for Use or Prescribing Information.
The recall record does not specify a remedy, so no action is required beyond checking if your product matches the listed codes.
The hazard is a discrepancy in marketing materials versus product instructions, which could lead to improper use during surgery but does not pose an immediate risk.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0658-2024 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0658-2024 from Baxter Healthcare. 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.
