P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
- Company
- Fort Defiance Industries, Llc
- Recall Initiated
- August 19, 2021
- Recall Number
- Z-0121-2022
- Quantity
- 380 devices
- Firm Location
- Loudon, TN
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.
Distribution
Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
Lot / Code Info
Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
Root Cause
Device Design
Action Taken
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."