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Recall Observatory FDA recall evidence

Device product

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

Z-0121-2022

August 19, 2021

Class II

Product summary

Firm
Fort Defiance Industries, LLC
Event
Event 88628
Status
Ongoing
Classification
Class II
Quantity
380 devices
Official record key
device-enforcement:Z-0121-2022

Official wording

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

Code information: Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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