# FDA recall Z-1344-2025

> **American Contract Systems Inc** · Class II · device recall initiated 2025-02-06.

## Product

LABOR & DELIVERY PPS    , Model No LLLD64O  LLLD64O-01  LLLD64O-02

## Reason for recall

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

## Distribution

US Nationwide distribution in the state of OH.

## Key facts

- **Recall number:** Z-1344-2025
- **Recalling firm:** American Contract Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-06
- **Report date:** 2025-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tiffin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1344-2025

## Citation

> AI Analytics. FDA recall Z-1344-2025. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1344-2025. Source: US FDA. Licensed CC0.

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