Reported Oct 27, 2021 · Ongoing

P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

Fort Defiance Industries, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fort Defiance Industries, LLC · 2411 Maremont Pkwy · Loudon, TN · 37774-1066

Is this the product you have?

  • P2131
  • Automated Field Steam Sterilizer NSN6530-01-641-4641
Lot codes and dates
  • Model numberP2131
  • NSN
    • 6530-01-641-4641
    • Serial Numbers AFS-0001 through AFS-0386
  • NoteAFS-0297 was not manufactured
Amount recalled
380 devices

Where it was sold

Why it was recalled

The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.