Reported Jul 18, 2018 · Terminated
FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort…
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?
- FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER
- NSN6530-01-641-4641
- Product UsageThe 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
- Lot codes and dates
- Serial NumbersAFS-0001 through AFS-0199
- Amount recalled
- 199 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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