FDA recall Z-0121-2022

Fort Defiance Industries, LLC · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2021-08-19
Report date
2021-10-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Loudon, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2022