# FDA recall Z-3237-2024

> **American Contract Systems, Inc.** · Class II · device recall initiated 2024-08-07.

## Product

Hand Pack, AKHD97C; Medical convenience kit

## Reason for recall

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

## Distribution

US Nationwide distribution in the states of MO, MN, MA, OH, NE.

## Key facts

- **Recall number:** Z-3237-2024
- **Recalling firm:** American Contract Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-07
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kansas City, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3237-2024

## Citation

> AI Analytics. FDA recall Z-3237-2024. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-3237-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
