Z-2411-2018Class II

Fdi Fort Defiance Industries P2131 Automated Field Steam Sterilizer, Nsn: 6530-01-641-4641

Name: Z-2411-2018 Fdi Fort Defiance Industries P2131 Automated Field Steam Sterilizer, Nsn: 6530-01-641-4641
Creator: Fort Defiance Industries, LLC
Published: 2018-05-24
License: https://open.fda.gov/license/

Fort Defiance Industries, LLC / initiated 2018-05-24 / Terminated / root cause: design

FDA source

Fort Defiance Industries, LLC began a recall of FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam... on 2018-05-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2411-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Posted: 2018-07-10
Terminated: 2023-06-27
Recalling firm: Fort Defiance Industries, LLC
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.
Product code: FLE Sterilizer, Steam
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 199 units
Distribution: US Nationwide Distribution in the states of PA. VA. TX
Product codes and lots: Serial Numbers: AFS-0001 through AFS-0199

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2411-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2411-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10

Product code FLE

K141009Class IIFort Defiance Automated Steam SterilizerFort Defiance Industries, Inc. / cleared 2014-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)