FDA recall Z-2411-2018

Fort Defiance Industries, LLC · Class II · device

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 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

Key facts

Status
Terminated
Initiation date
2018-05-24
Report date
2018-07-18
Termination date
2023-06-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Loudon, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2411-2018