Baxter Peri-Guard Repair Patch Contraindication Added for Neurosurgery
Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.
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 an FDA Class II medical device recall identifying a contraindication for use in neurosurgery due to endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. This represents a risk-of-harm situation for a critical application, meeting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling the Peri-Guard Repair Patch (product codes PG0404, PG0608, PG0814, PG1016, and PG1225) due to a newly identified contraindication. The contraindication restricts the use of this device in neurosurgery because endotoxin levels in the product may exceed the allowable limit for cerebrospinal fluid-contacting devices.
2413 units of the affected product codes have been distributed within the United States (Connecticut, Virginia, Texas, Pennsylvania, and Illinois) and internationally (Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and United Kingdom). All affected lots remain within their expiration dates.
Healthcare facilities that have received this device should review the updated instructions for use and avoid using Peri-Guard Repair Patch in neurosurgical procedures.
The recalled product
- Product
- Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Surgical Patch
- Affected units
- 2,413
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) PG0404
- UDI/DI 00085412818405
- b) PG0608
- UDI/DI 00085412818443
- c) PG0814
- UDI/DI 00085412818597
- d) PG1016
- UDI/DI 00085412818610
- e) PG1225
- UDI/DI 00085412818658
- 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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