Baxter recalls Peri-Guard Repair Patches with specific codes due to potential endotoxin levels exceeding neurosurgery safety limits. Affected units may not be used in neurosurgery procedures.
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 certain Peri-Guard Repair Patches that may have endotoxin levels too high for neurosurgery use. This could pose a risk if used in procedures involving cerebrospinal fluid.
The patches may contain endotoxins at levels higher than safe limits for cerebrospinal fluid contact. This could lead to infections or other complications during neurosurgery if used improperly.
Healthcare professionals using these patches in neurosurgery procedures are most at risk. Patients undergoing neurosurgery with these patches could face potential complications.
Check for product codes PC0404SNBIO, PC0608NSBIO, PC0814SNBIO, or PC1016SNBIO. These patches were sold with specific UDI/DI numbers and within their expiration dates.
Identify if your patch has one of the listed product codes: PC0404SNBIO, PC0608NSBIO, PC0814SNBIO, or PC1016SNBIO.
The recall is due to a new contraindication in the instructions stating that these patches may have endotoxin levels higher than safe limits for neurosurgery use.
The recall specifically addresses neurosurgery use; these patches may be safe for other medical procedures if not used in neurosurgery.
Check for product codes PC0404SNBIO, PC0608NSBIO, PC0814SNBIO, or PC1016SNBIO on the patch label.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1378-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1378-2024 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.
