Baxter recalls Peri-Guard Repair Patches (PG0404, PG0608, PG0814, PG1016, PG1225) for neurosurgery use due to potential endotoxin levels exceeding safety limits for cerebrospinal fluid contact.
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
Baxter is recalling Peri-Guard Repair Patches with specific product codes because they may have endotoxin levels too high for use in neurosurgery. This could pose a risk to patients during spinal surgery if the patches come into contact with cerebrospinal fluid.
The Peri-Guard Repair Patches may contain endotoxin levels higher than the safe limit for devices that contact cerebrospinal fluid. This could lead to infections or complications during neurosurgery if the patches are used in spinal procedures.
Healthcare professionals using these patches in neurosurgery are most at risk. Patients undergoing spinal surgery may be affected if the patches are used incorrectly.
Check the product code on the patch: PG0404, PG0608, PG0814, PG1016, or PG1225. These patches were sold with specific unique identifiers (UDI/DI) listed in the recall notice.
Identify the product code on the patch (PG0404, PG0608, PG0814, PG1016, or PG1225) to confirm if it is recalled.
Baxter added a new contraindication to the instructions stating these patches should not be used in neurosurgery due to potential endotoxin levels exceeding safety limits for cerebrospinal fluid contact.
The recall specifically addresses neurosurgery use; these patches may be safe for other medical procedures if not used in spinal surgery.
Look for product codes PG0404, PG0608, PG0814, PG1016, or PG1225 on the patch, along with the unique identifiers (UDI/DI) listed in the recall notice.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1379-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1379-2024 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.
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.
