Recall Z-2411-2018— Fort Defiance Industries, LLC

Name: FDA recall Z-2411-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-24

Class II · Terminated

Class II FDA medical device recall by Fort Defiance Industries, LLC, initiated 2018-05-24, terminated 2023-06-27. It names one FDA 510(k) clearance: K141009. 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..

Recalling firm: Fort Defiance Industries, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Terminated: 2023-06-27
Firm location: Loudon, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K141009 — FORT DEFIANCE AUTOMATED STEAM STERILIZERFort Defiance Industries, Inc.·cleared 2014-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.