Baxter Supple Peri-Guard Repair Patch — Class II medical device recall Z-1378-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-04-03, distributed in CT, IL, PA, TX, VA. A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in ne
| Recall number | Z-1378-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-02-28 |
| Classified | 2024-03-26 |
| Reported by FDA | 2024-04-03 |
| Distributed | CT, IL, PA, TX, VA |
| Countries outside the US | AT, CH, DE, ES, FI, GB, GR, IE, IT, PL, SE |
| Quantity | 9,549 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00085412530642, 00085412530673, 00085412530697, 00085412530710 |
Product
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1378-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.