device · product 1 of 1
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.
- Recall number
- Z-1952-2018
- Initiated
- April 17, 2018
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Gyrus Acmi, Incorporated
- Quantity
- 6447
App-derived interpretation
There is a potential for the cord to spark and cause a fire.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
There is a potential for the cord to spark and cause a fire.
Code information
All lots manufactured before December 7, 2017 UDI (00821925008700)
Distribution pattern
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.