Baxter Supple Peri-Guard Repair Patch Recall Due to Endotoxin Contraindication
Baxter is recalling Supple Peri-Guard Repair Patch units due to elevated endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
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: FDA Class II recall of a risk-of-harm product where no illnesses or injuries have been reported. Endotoxin contamination in cerebrospinal fluid-contacting devices poses a genuine safety hazard to the central nervous system, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling certain Supple Peri-Guard Repair Patch units (product codes PC0404SNBIO, PC0608NSBIO, PC0814SNBIO, PC1016SNBIO) due to endotoxin contamination risk. The recall affects 9,549 units distributed to facilities in Connecticut, Virginia, Texas, Pennsylvania, Illinois, and several countries including Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and the United Kingdom.
The FDA Class II recall was initiated after Baxter added a new contraindication to the product's instructions for use. Endotoxin levels in the product may exceed the allowable limit for cerebrospinal fluid-contacting devices, creating a potential safety risk if used in neurosurgery.
Healthcare facilities that have received these products should review their inventory and cease use of affected units in neurosurgical applications. All lot numbers are still within their expiration dates. For product disposal or return guidance, contact Baxter Healthcare Corporation or the FDA.
The recalled product
- Product
- Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 9,549
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) PC0404SNBIO
- UDI/DI 00085412530642
- b) PC0608SNBIO
- UDI/DI 00085412530673
- c) PC0814SNBIO
- UDI/DI 00085412530697
- d) PC1016SNBIO
- UDI/DI 00085412530710
- 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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