CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
Baxter Peri-Guard Repair Patch (new product codes) recalled
Baxter Healthcare is recalling Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d), distributed in Connecticut, Illinois, Pennsylvania, Texas, Virginia. The recall was initiated on 28 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1379-2024
- FDA event ID
- 94152
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Feb 2024
- FDA classified
- 26 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Feb 2024 | Recall initiated by company | |
| 26 Mar 2024 | Classified by FDA | +27 days |
| 3 Apr 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Where it was distributed
US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and United Kingdom.
Questions about this recall
Is Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) recalled?
Yes. Baxter Healthcare recalled Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) on 28 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1379-2024.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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