Baxter recalls Peri-Guard Repair Patches (PC0404NBIO, PC0608NBIO, PC0814NBIO, PC1016NBIO) 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 four specific Peri-Guard Repair Patch models because they may have endotoxin levels too high for use in neurosurgery. This could pose a risk if used near cerebrospinal fluid, potentially causing infection or other complications.
The patches may contain endotoxin levels higher than allowed for devices that contact cerebrospinal fluid. This could lead to infections or other complications if used during neurosurgery procedures.
Healthcare professionals using these patches in neurosurgery procedures are most at risk. Patients undergoing neurosurgery with these patches could face potential infection risks.
Check for product codes PC0404NBIO, PC0608NBIO, PC0814NBIO, or PC1016NBIO on the patch packaging. These patches were sold with specific UDI/DI numbers and within their expiration dates.
Identify if your patch has one of the product codes PC0404NBIO, PC0608NBIO, PC0814NBIO, or PC1016NBIO.
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 near cerebrospinal fluid.
The recall does not specify a remedy, so you should check with your healthcare provider or Baxter for guidance on whether to continue using the patch.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1377-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1377-2024 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.
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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.
