Baxter Supple Peri-Guard Repair Patch contraindicated for neurosurgery due to endotoxin
Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed 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 medical device recall with no reported illnesses or injuries. The product presents a risk-of-harm in a critical application (cerebrospinal fluid contact in neurosurgery) due to elevated endotoxin levels, meeting the criterion for High severity as a risk-of-harm product without reported injury.
Plain-English summary
Baxter Healthcare Corporation has recalled Supple Peri-Guard Repair Patch (product codes SPG0404, SPG0406, SPG0608, SPG0814, and SPG1016) across all lot codes within expiry. A new contraindication has been added to the product's instructions for use.
The recalled product has endotoxin levels that may exceed the allowable limit for devices that contact cerebrospinal fluid. Due to this risk, the patch should not be used in neurosurgery applications where such contact may occur.
The recall affects 4774 units distributed in the United States (Connecticut, Virginia, Texas, Pennsylvania, and Illinois) and internationally (Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and the United Kingdom).
Healthcare facilities that received this product should not use it for neurosurgical applications. Contact Baxter Healthcare Corporation with questions regarding this recall.
The recalled product
- Product
- Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 4,774
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 (11)
- a) SPG0404
- UDI/DI 00085412818672
- b) SPG0406
- UDI/DI 00085412818696
- c) SPG0608
- UDI/DI 00085412818313
- d) SPG0814
- UDI/DI 00085412818375
- e) SPG1016
- UDI/DI 00085412818429
- 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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