Z-2411-2018 Class II Terminated
FDA device recall Z-2411-2018 was initiated by Fort Defiance Industries, LLC on May 24, 2018 and is designated Class II. 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 i… The recall status is terminated (terminated June 27, 2023). Affected quantity: 199 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2018
- Initiation Date
- May 24, 2018
- Termination Date
- June 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 199 units
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.
Distribution Pattern
US Nationwide Distribution in the states of PA. VA. TX
Code Information
Serial Numbers: AFS-0001 through AFS-0199