FDA-Device2021-10-27Class II
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Fort Defiance Industries, LLC
Hazard
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
Sold states
Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
Affected count
380 devices
Manufactured in
2411 Maremont Pkwy, N/A, Loudon, TN, United States
Products
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2022Don't want to check this manually?
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