# FDA recall Z-0668-2024

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2023-12-06.

## Product

PERI-GUARD SUPPLE, Product Codes:    a)	SPG1016:  10X16 CM US, TS;   b)	SPG0404:  4 X 4 CM US, TS;   c)	SPG0608:  6 X 8 CM US, TS;   d)	SPG0814:  8 X 14 CM US, TS;   e)	PC1016SNBIO: 10X16 CM US;   f)	PC0404SNBIO: 4X4 CM US;   g)	PC0608SNBIO: 6X8 CM US;   h)	PC0814SNBIO: 8X14 CM US

## Reason for recall

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0668-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-06
- **Report date:** 2024-01-17

- **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-0668-2024

## Citation

> AI Analytics. FDA recall Z-0668-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0668-2024. Source: US FDA. Licensed CC0.

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