Z-0121-2022 Class II Ongoing
FDA device recall Z-0121-2022 was initiated by Fort Defiance Industries, LLC on August 19, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 380 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- August 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 380 devices
Product Description
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
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 Pattern
Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
Code Information
Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.