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Na P2131

by Fort Defiance Industries, Inc. GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862992000303 UDI-DIDate20 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-2983-2026 FDA Class II initiated 8 Jul 2026

    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 fault current return path.

    • Ongoing Z-0121-2022 FDA Class II initiated 19 Aug 2021

    The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

    • Terminated Z-2411-2018 FDA Class II initiated 24 May 2018

    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.

Specification

GUDID

Generic Name
Steam sterilizer
Model / Reference
P2131
Primary DI / UDI-DI
00862992000303
510(k) Number
FDA Product Code
FLE
GMDN Term
Steam sterilizer
Device Class
Class II
Regulation Number
880.6880
GUDID distribution status
In Commercial Distribution
Size
Weight — 532 Pound
Height — 62 Inch
Width — 39.75 Inch
Length — 38 Inch

Related devices

Category: Steam sterilizer

Cleared under the same submission (K141009)

Other devices from Fort Defiance Industries, Inc.

See all devices from Fort Defiance Industries, Inc. →

Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No