# FDA recall Z-1377-2024

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2024-02-28.

## Product

Baxter Peri-Guard Repair Patch (legacy product codes):    a) PC0404NBIO,   b) PC0608NBIO,  c) PC0814NBIO,   d) PC1016NBIO

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1377-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-28
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1377-2024

## Citation

> AI Analytics. FDA recall Z-1377-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1377-2024. Source: US FDA. Licensed CC0.

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