The Recall Desk
SevereFDA (Devices)·Z-1952-2018·Announced 2018-06-06

Gyrus ACMI Reusable Active Cord Recalled for Fire Hazard

Gyrus Acmi is recalling 6,447 reusable active cords for electrosurgical generators due to a potential risk of sparking and causing a fire.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a potential for fire, which poses a risk of significant injury or property damage, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Gyrus Acmi, Incorporated is recalling 6,447 units of the Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators (Catalog No C650-129A). The recall includes all lots manufactured before December 7, 2017. These cords are designed to connect Gyrus ACMI working elements to monopolar electrosurgical generators and are provided non-sterile for reuse.

The recall is being conducted because there is a potential for the cord to spark and cause a fire. The affected products were distributed nationwide in the United States and internationally to Japan, Canada, Mexico, Australia, and the EU.

Healthcare facilities and users should stop using the affected cords immediately. Gyrus Acmi is the recalling firm responsible for managing the recall process.

The recalled product

Product
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
Manufacturer
Gyrus Acmi, Incorporated
Category
Medical Device — Electrosurgical Equipment
Hazard
Affected units
6,447

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Related recalls

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Same hazard · fire

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