Moderate riskFDA DeviceClass II

FDI field steam sterilizer recalled for loss of electrical ground

Fort Defiance Industries is recalling its Automated Field Steam Sterilizer because the 120V connector on the water recovery system may intermittently lose its ground connection. This could make the electrical fault current path unreliable. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact Fort Defiance Industries for instructions before continuing to use the affected sterilizer.
  2. Check the serial numbers on your unit against the recall notice.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Illnesses reported
None reported
Manufactured in
2411 Maremont Pkwy, Loudon, TN, United States
Classification
Class II
Recall number
Z-2983-2026

In the FDA's words

Description
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path. Lot Code: All serial numbers/ GTIN: (01) 00862992000327 Distribution: Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.
Hazard
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.

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