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.
- Company
- Fort Defiance Industries, Llc
- Recall Initiated
- May 24, 2018
- Terminated
- June 27, 2023
- Recall Number
- Z-2411-2018
- Quantity
- 199 units
- Firm Location
- Loudon, TN
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.
Distribution
US Nationwide Distribution in the states of PA. VA. TX
Lot / Code Info
Serial Numbers: AFS-0001 through AFS-0199
Root Cause
Device Design
Action Taken
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.