FDA Device recall Z-1379-2024
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225 by Baxter Healthcare, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1379-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-28 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | CT, IL, PA, TX, VA |
Product
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Reason
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.
Identifiers
| code_info | a) PG0404, UDI/DI 00085412818405; b) PG0608, UDI/DI 00085412818443; c) PG0814, UDI/DI 00085412818597; d) PG1016, UDI…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1379-2024%22
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