FDA recall Z-2553-2019

GN Otometrics · Class II · device

Product

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwi

Reason for recall

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

Distribution

Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Macedonia, The Former Yugoslav, Malaysia, Maldives, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine,

Key facts

Status
Ongoing
Initiation date
2019-08-01
Report date
2019-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Taastrup, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2553-2019