Baxter Healthcare recalls PERI-GUARD SUPPLE products with inaccurate marketing brochures that don't match product instructions. Consumers should check product codes and serial numbers for affected items.
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 SUPPLE products due to marketing brochures containing inaccurate content that doesn't align with product instructions or prescribing information. This recall doesn't pose a safety risk but requires consumers to verify their product codes to avoid confusion.
The marketing brochures distributed with these products contain inaccurate information that doesn't match the product's actual instructions for use or prescribing information. This could lead to misunderstandings about how to safely use the products during cardiovascular surgery procedures.
Current owners of PERI-GUARD SUPPLE products with specific product codes (SPG1016, SPG0404, SPG0608, SPG0814, PC1016SNBIO, PC0404SNBIO, PC0608SNBIO, PC0814SNBIO) sold in the US. Medical professionals using these products for cardiovascular surgery are most at risk due to potential confusion with instructions.
Check for product codes: SPG1016 (10x16 cm), SPG0404 (4x4 cm), SPG0608 (6x8 cm), SPG0814 (8x14 cm), or PC1016SNBIO, PC0404SNBIO, PC0608SNBIO, PC0814SNBIO (all sizes). The products were sold in the US with specific serial numbers and UDI/DI codes listed in the recall notice.
Identify if your PERI-GUARD SUPPLE product matches the listed codes: SPG1016, SPG0404, SPG0608, SPG0814, PC1016SNBIO, PC0404SNBIO, PC0608SNBIO, or PC0814SNBIO.
Baxter Healthcare recalls these products because the marketing brochures contain inaccurate content that doesn't align with the product's instructions for use or prescribing information.
No, this recall does not pose a safety risk. The products can be used normally, but consumers should verify their product codes to avoid confusion with instructions.
Check for product codes: SPG1016 (10x16 cm), SPG0404 (4x4 cm), SPG0608 (6x8 cm), SPG0814 (8x14 cm), or PC1016SNBIO, PC0404SNBIO, PC0608SNBIO, PC0814SNBIO (all sizes).
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0668-2024 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0668-2024 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.
