Recall Z-1952-2018— Gyrus Acmi, Incorporated
Class II · Terminated
Class II FDA medical device recall by Gyrus Acmi, Incorporated, initiated 2018-04-17, terminated 2023-09-18. It names one FDA 510(k) clearance: K890328. 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 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.. Reason: There is a potential for the cord to spark and cause a fire..
- Recalling firm
- Gyrus Acmi, Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-17
- Terminated
- 2023-09-18
- Firm location
- Southborough, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
There is a potential for the cord to spark and cause a fire.
Data sourced from openFDA. This site is unofficial and independent of the FDA.