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Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab… recallZ-1952-2018 · Gyrus Acmi, Incorporated · initiated Apr 17, 2018

Terminated

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 Gyrus Acmi, Incorporated 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

There is a potential for the cord to spark and cause a fire.

FDA root cause category: Device Design

What the company is doing

Notification letters were distributed on April 17, 2018. The letters instruct customers to perform the following: Immediately assess any affected product you have in stock and replace the IFU with the revised IFU. Also ensure that any potential users of the devices are aware of the additional warning in the revised IFU. Future versions of the IFU will include the warning. Remove and discard all cords in use greater than one year. If you need additional copies of the IFU, call your Olympus customer service representative at 1-888-524-7266 to arrange for them to be provided. Please note on the enclosed Reply Form that you have received this information. Fax the completed Reply Form to 484-896-7128 regardless of whether you have any affected inventory at your facility. In addition, if you may have further distributed this product, please identify your customers, inform them at once of this action, provide the revised IFU and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this letter. For further questions, please call (508) 804-2600.

Recall details

Recall number
Z-1952-2018
Status
Terminated
Initiated by the company
Apr 17, 2018
Recalling firm
Gyrus Acmi, Incorporated
Quantity
6447
Product code
FAS
FDA submissions
K890328
Distribution
Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Japan, Canada, Mexico, Australia, and EU.

Product description

Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.

Code information (models, lots, serial numbers)

All lots manufactured before December 7, 2017  UDI (00821925008700)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

39 devices cleared under K890328 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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