Baxter Peri-Guard Repair Patch contraindicated for neurosurgical use
Peri-Guard Repair Patch is now contraindicated for neurosurgery because its endotoxin level may exceed the limit allowable for cerebrospinal fluid-contacting devices. Product instructions have been updated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with a substantial hazard—endotoxin exceeding allowable limits for cerebrospinal fluid contact—but no reported illnesses or injuries. It meets the High severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling specific lots of Peri-Guard Repair Patch, a medical device used in surgical repair. The affected products are identified by codes PC0404NBIO, PC0608NBIO, PC0814NBIO, and PC1016NBIO, with approximately 9,899 units distributed.
A contraindication has been added to the product's Instructions for Use stating that Peri-Guard Repair Patch should not be used in neurosurgical procedures. The product's endotoxin level may exceed the allowable limit for devices that contact cerebrospinal fluid, posing a safety risk if used in neurosurgery.
The recall affects healthcare facilities in Connecticut, Virginia, Texas, Pennsylvania, and Illinois, as well as in Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and the United Kingdom. Healthcare providers should review their use of this product and ensure it is not used for neurosurgical applications. All affected lots are within their expiration date.
The recalled product
- Product
- Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 9,899
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- a) PC0404NBIO
- UDI/DI 00085412530529
- b) PC0608NBIO
- UDI/DI 00085412530567
- c) PC0814NBIO
- UDI/DI 00085412530581
- d) PC1016NBIO
- UDI/DI 00085412530604
- ALL LOTS WITHIN EXPIRY
Distribution
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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