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Recall Observatory FDA recall evidence

Device 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.

Z-2411-2018

May 24, 2018

Class II

Product summary

Firm
Fort Defiance Industries, LLC
Event
Event 80293
Status
Terminated
Classification
Class II
Quantity
199 units
Official record key
device-enforcement:Z-2411-2018

Official wording

Reason: 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.

Code information: Serial Numbers: AFS-0001 through AFS-0199

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.