Recall Z-0121-2022 ยท FLE Sterilizer, Steam
Fort Defiance Industries, LLC
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
| Date | Aug 19, 2021 |
| Status | Open, Classified |
| Reason | The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground. |
| Root cause | Device Design |
| 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 |
| Quantity | 380 devices |
| Distribution | Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER Fort Defiance Industries, Inc., Dec 16, 2014 |