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Hand Control 12FR Suction Coagulator with 10 ft cord and… recallZ-1151-2014 · Megadyne Medical Products, Inc. · initiated Feb 27, 2014

Class II Terminated All recalls posted in March 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Megadyne Medical Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Use error

What the company is doing

Megadyne Medical Product sent an Urgent Medical Device Recall letter dated February 27, 2014, to all affected customers with follow-up phone calls and emails. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed toexamine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to remove the product from service and contact Megadyne Customer Service at 1-801-576-9669 or 1-800-747-6110 for return authorization and replacement or credit. If customers have distributed any the affected product, they were instructed to immediately contact their distribution points to have the product returned to Megadyne. Customers with questions were instructed to contact Customer Service at 1-800-747-6110 or 1-801-576-9669 or email Regulatory @Megadyne.com. For questions regarding this recall call 801-576-9669.

Recall details

Recall number
Z-1151-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 27, 2014
Posted by the FDA
Mar 7, 2014
Recalling firm
Megadyne Medical Products, Inc.
Quantity
494
Product code
GEI
FDA submissions
K072559
Distribution
USA including FL, MN, LA, NJ, NM, PA, TX and Internationally to Canada.

Product description

Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

6 devices cleared under K072559 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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