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 their marketing brochures contain inaccurate information that doesn't align with the product's instructions or prescribing details. This could lead to confusion about how to use the patches correctly.
The marketing brochures distributed with the patches contain inaccurate content that doesn't match the product's official instructions or prescribing information. This mismatch could cause confusion about proper use, but it doesn't pose a direct physical risk like injury or malfunction.
Patients and healthcare providers who use Peri-Guard Repair Patches with the listed product codes may be affected. Those most at risk are individuals who rely on the patches for cardiovascular surgery procedures.
Check for product codes: PC1016NBIO (10x16cm), PC1225NBIO (12x25cm), PC0404NBIO (4x4cm), PC0608NBIO (6x8cm), or PC0814NBIO (8x14cm). The patches also have specific UDI/DI numbers listed in the recall notice.
Look for the product codes listed in the recall: PC1016NBIO, PC1225NBIO, PC0404NBIO, PC0608NBIO, or PC0814NBIO.
The marketing brochures distributed with these patches contain inaccurate content that doesn't align with the product's instructions or prescribing information.
The recall doesn't require immediate action; check the product codes to see if you have a recalled item.
No direct safety risks are mentioned; the issue is about inaccurate marketing information, not physical harm.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0665-2024 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0665-2024 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.
