Baxter recalls Peri-Guard Repair Patches (SPG0404, SPG0406, SPG0608, SPG0814, SPG1016) due to potential endotoxin levels exceeding neurosurgery safety limits.
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 specific Peri-Guard Repair Patches for neurosurgery use because the product's endotoxin levels might exceed safe limits for cerebrospinal fluid contact. This could pose a risk to patients during neurosurgery procedures.
The Peri-Guard Repair Patches may have endotoxin levels higher than the safe limit for devices that contact cerebrospinal fluid. This could lead to infections or other complications during neurosurgery.
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 SPG0404, SPG0406, SPG0608, SPG0814, or SPG1016. These patches were sold with specific unique identifiers (UDI/DI) listed in the recall notice.
Identify if your patch has one of the product codes SPG0404, SPG0406, SPG0608, SPG0814, or SPG1016.
Baxter added a new contraindication in the instructions stating these patches should not be used in neurosurgery due to potential endotoxin levels exceeding safe limits for cerebrospinal fluid-contacting devices.
The affected product codes are SPG0404, SPG0406, SPG0608, SPG0814, and SPG1016.
The recall states these patches should not be used in neurosurgery, but there is no instruction to stop using them for other purposes.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1380-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1380-2024 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.
