RecallRadar

FDA Device recall Z-2411-2018

FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Auto…

On 2018-07-18 the FDA classified a Class II recall of FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Auto… by Fort Defiance Industries, citing 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 t….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2411-2018
ClassificationClass II
Statusterminated
Initiated2018-05-24
Published2018-07-18
Last updated2026-09-13 11:54 UTC
CompanyFort Defiance Industries
DistributionUS

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

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.

Identifiers

code_infoSerial Numbers: AFS-0001 through AFS-0199

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2411-2018%22

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