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U.S. Department of Health and Human Services

Class 2 Device Recall P2131 AUTOMATED FIELD STEAM STERILIZER

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  Class 2 Device Recall P2131 AUTOMATED FIELD STEAM STERILIZER see related information
Date Initiated by Firm May 24, 2018
Create Date July 10, 2018
Recall Status1 Open3, Classified
Recall Number Z-2411-2018
Recall Event ID 80293
510(K)Number K141009  
Product Classification Sterilizer, steam - Product Code FLE
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.
Code Information Serial Numbers: AFS-0001 through AFS-0199
Recalling Firm/
Manufacturer
Fort Defiance Industries, LLC
2411 Maremont Pkwy
Loudon TN 37774-1066
For Additional Information Contact
865-408-0100
Manufacturer 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.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FLE and Original Applicant = Fort Defiance Industries, Inc.
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