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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
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