Recall Z-0121-2022— Fort Defiance Industries, LLC

Name: FDA recall Z-0121-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-19

Class II · Ongoing

Class II FDA medical device recall by Fort Defiance Industries, LLC, initiated 2021-08-19. It names one FDA 510(k) clearance: K141009. Product: P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641. Reason: The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground..

Recalling firm: Fort Defiance Industries, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-08-19
Firm location: Loudon, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K141009 — FORT DEFIANCE AUTOMATED STEAM STERILIZERFort Defiance Industries, Inc.·cleared 2014-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.