FDAClass IIMarch 19, 2014

Hand Control 12FR Suction Coagulator with 10 ft cord recall

Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25…

Why was Hand Control 12FR Suction Coagulator with 10 ft cord recalled?

Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018

Product
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25…
Recalling firm
Megadyne Medical Products, Inc.
Quantity
494
Distribution
USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.
Recall date
March 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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