Baxter Healthcare recalls Peri-Guard Repair Patches with specific product codes due to inaccurate marketing brochures that don't match product instructions or prescribing information.
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 Peri-Guard Repair Patches with specific product codes because marketing brochures contain inaccurate content that doesn't align with the product's instructions or prescribing information. This issue could lead to confusion about how to use the patches correctly.
The marketing brochures distributed with the patches have inaccurate content that doesn't match the product's official instructions or prescribing information. This mismatch could cause confusion about proper use, but it does not pose a direct safety risk like a physical hazard.
Patients and healthcare providers who use Peri-Guard Repair Patches with the listed product codes. Those most at risk are individuals who rely on the patches for cardiovascular surgery procedures.
Check the product code on the patch: PG1016 (10x16 cm), PG1225 (12x25 cm), PG0404 (4x4 cm), PG0608 (6x8 cm), or PG0814 (8x14 cm). Also look for the unique identification numbers (UDI/DI) listed for each product code.
Identify the product code on the patch (PG1016, PG1225, PG0404, PG0608, or PG0814) and the corresponding unique identification number.
The marketing brochures distributed with these patches contain inaccurate content that doesn't align with the product's instructions or prescribing information.
Check the product code on the patch: PG1016 (10x16 cm), PG1225 (12x25 cm), PG0404 (4x4 cm), PG0608 (6x8 cm), or PG0814 (8x14 cm). Also look for the unique identification numbers (UDI/DI) listed for each product code.
No action is required beyond checking the product code and unique identification number. The recall is for informational purposes to ensure accurate use.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0664-2024 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0664-2024 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.
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.
