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FORT DEFIANCE INDUSTRIES, LLC · Model P2131-3 · UDI-DI 00862992000334

FLE

510(k) clearances

1,513

Adverse events (1 deaths)

Recalls

Facilities

Description

The P2131-3 Sterilizer Water Softener (SWS) is the component that filters and de-mineralizes the incoming water to prevent scale build-up in the P2131 Automated Field Sterilizer system. The P2131 is an automated, pre- and post-vacuum steam sterilizer 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 field use in a variety of austere environments. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer Main Unit (SMU), (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS).

Recalls

Date	Firm	Reason
2026-07-08	Fort Defiance Industries, LLC	The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable f
2023-06-22	Scican Ltd.	The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized ste
2023-06-22	Scican Ltd.	The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized ste
2021-08-19	Fort Defiance Industries, LLC	The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
2019-10-22	Steris Corporation	Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
2019-10-22	Steris Corporation	The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and lo
2019-04-18	Skytron, Div. The KMW Group, Inc	Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
2018-12-26	Steris Corporation	The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly slid
2018-05-24	Fort Defiance Industries, LLC	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 th
2015-09-03	Steris Corporation	In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.