FDAClass IIOctober 27, 2021

P2131 Automated Field Steam Sterilizer NSN recall

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

Why was P2131 Automated Field Steam Sterilizer NSN recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Recalling firm
Fort Defiance Industries, LLC
Quantity
380 devices
Distribution
Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.
Recall date
October 27, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls