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Open, Classified

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

FDA Recall Z-0121-2022 · Posted None

Recalling FirmFort Defiance Industries, LLC
Recall StatusOpen, Classified
Product CodeFLE
Date Initiated2021-08-19
Product Quantity380 devices

Reason for Recall

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

Firm Action

A Recall notification letter titled, "MEDICAL DEVICE ADVISORY NOTICE" was sent to consignees on 08/19/2021 via a email. The notice provides instructions regarding continued use of the device until FDI provides a protective cover for the rear heater plate and cover assembly. It mentions, "THE OPERATOR SHOULD NOT TOUCH THE REAR HEATER PLATE AND COVER ASSEMBLY OF THE DEVICE WHILE THE DEVICE IS IN USE OR POWERED ON. IF ACCESS TO THE REAR OF THE DEVICE IS REQUIRED, PLEASE TURN THE POWER OF THE UNIT OFF USING THE FRONT PANEL SWITCH OR DISCONNECT INCOMING POWER TO THE DEVICE. DO NOT ATTEMPT TO MODIFY THE DEVICE TO CHANGE THE ELECTRICAL GROUND CONDITION OF THE HEATER PLATE AND COVER ASSEMBLY AS THIS WILL IMPACT DEVICE PERFORMANCE."

Root Cause

Device Design

Distribution Pattern

Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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