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Terminated

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.

FDA Recall Z-2411-2018 · Posted None

Recalling FirmFort Defiance Industries, LLC
Recall StatusTerminated
Product CodeFLE
Date Initiated2018-05-24
Date Terminated2023-06-27
Product Quantity199 units

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.

Firm Action

Fort Defiance Industries (FDI) notified the consignees by email on 05/24/2018. The letter explained the issue. FDI has revised the (1) Installation, Operational, and Performance Qualification (IQ/OQ/PQ) activities, (2) preparation for transport / storage, (3) preventive maintenance, and (4) device warning statements. FDI has revised the procedures for safety switch verification during IQ/OQ/PQ and complete water drainage before transport / storage of the device.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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