P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Summary
The FDA issued a Class II for P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 by Fort Defiance Industries, LLC. Reason: The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground..
Details
Source
Device Recall
External ID
Z-0121-2022
Action Date
2021-10-27
Status
Ongoing
Category
device
Product Description
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Lot/Code Info: Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
Quantity Affected: 380 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-19
Company
Loudon, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fort Defiance Industries, LLC has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fort Defiance Industries, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fort Defiance Industries, LLC have FDA actions?
Fort Defiance Industries, LLC has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0121-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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