FDA Device recall Z-1380-2024
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016 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-1380-2024 |
| 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 Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
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) SPG0404, UDI/DI 00085412818672; b) SPG0406, UDI/DI 00085412818696; c) SPG0608, UDI/DI 00085412818313; d) SPG0814,…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 |
|---|
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-1380-2024%22
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