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U.S. Department of Health and Human Services

Class 2 Device Recall P2131 Automated Field Steam Sterilizer

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  Class 2 Device Recall P2131 Automated Field Steam Sterilizer see related information
Date Initiated by Firm August 19, 2021
Create Date October 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-0121-2022
Recall Event ID 88628
510(K)Number K141009  
Product Classification Sterilizer, steam - Product Code FLE
Product P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Code Information Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
Recalling Firm/
Manufacturer		 Fort Defiance Industries, LLC
2411 Maremont Pkwy
Loudon TN 37774-1066
For Additional Information Contact
865-408-0100
Manufacturer 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.
FDA Determined
Cause 2		 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 THE DEVICE TO CHANGE THE ELECTRICAL GROUND CONDITION OF THE HEATER PLATE AND COVER ASSEMBLY AS THIS WILL IMPACT DEVICE PERFORMANCE."
Quantity in Commerce 380 devices
Distribution Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FLE and Original Applicant = Fort Defiance Industries, Inc.
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