Z-1952-2018 Class II Terminated
FDA device recall Z-1952-2018 was initiated by Gyrus Acmi, Incorporated on April 17, 2018 and is designated Class II. Reason for recall: There is a potential for the cord to spark and cause a fire. The recall status is terminated (terminated September 18, 2023). Affected quantity: 6447.
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- April 17, 2018
- Termination Date
- September 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6447
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.
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.
Code Information
All lots manufactured before December 7, 2017 UDI (00821925008700)