---
title: "Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO,... — FDA record Z-1378-2024 | Is It on Recall"
description: "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 b"
url: https://isitonrecall.com/recall/fda-device-z-1378-2024-baxter-supple-peri-guard-repair-patch-legacy-product-codes-a-pc0404snbio-b-pc0608nsbio-c-pc0814snbio/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC10... — FDA record Z-1378-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 28, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
- **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.
- **Classification**: Class II
- **Recalling firm**: Baxter Healthcare Corporation
- **Quantity**: 9549 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1378-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1378-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | a) PC0404SNBIO, UDI/DI 00085412530642; b) PC0608SNBIO, UDI/DI 00085412530673; c) PC0814SNBIO, UDI/DI 00085412530697; d) PC1016SNBIO, UDI/DI 00085412530710; ALL LOTS WITHIN EXPIRY |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Apr 3, 2024
- **Recall initiation date**: Feb 28, 2024
- **Center classification date**: Mar 26, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1378-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Baxter Healthcare Corporation records](https://isitonrecall.com/brand/baxter-healthcare-corporation/)