# FDA recall Z-2411-2018

> **Fort Defiance Industries, LLC** · Class II · device recall initiated 2018-05-24.

## Product

FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641    Product Usage:  The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.

## Reason for recall

During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system that can potentially interfere with the rear sight gauge and / or the water liquid level switch.

## Distribution

US Nationwide Distribution in the states of PA. VA. TX

## Key facts

- **Recall number:** Z-2411-2018
- **Recalling firm:** Fort Defiance Industries, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-24
- **Report date:** 2018-07-18
- **Termination date:** 2023-06-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Loudon, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2411-2018

## Citation

> AI Analytics. FDA recall Z-2411-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2411-2018. Source: US FDA. Licensed CC0.

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