Recall Z-2411-2018 ยท FLE Sterilizer, Steam
Fort Defiance Industries, LLC
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 designe
| Date | May 24, 2018 |
| Status | Terminated |
| 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. |
| 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 | 199 units |
| Distribution | US Nationwide Distribution in the states of PA. VA. TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER Fort Defiance Industries, Inc., Dec 16, 2014 |