FDA Enforcement Class II Ongoing

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 Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

Recall: Z-2553-2019 · Reported October 2, 2019

Enforcement

Recall Number: Z-2553-2019
Event ID: 83491
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: GN Otometrics
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: October 2, 2019
Initiation Date: August 1, 2019
Classification Date: September 23, 2019
Address: Horskatten 9, Taastrup, N/A, Denmark

Description

Reason

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

Code Info

Part Numbers: 1. 7590310-24; 2. 7590310-40; 3. 7590311-24; 4. 7590311-40; 5. 7590312-24; 6. 7590312-40; 7. 7590313-24; 8. 7590313-40; 9. 7590314-24; 10. 7590314-40; 11. 7590315-24; 12. 7590315-40; 13. 7590316-24; 14. 7590316-40; 15. 7590317-24; 16. 7590317-40; 17. 7590318-24-5; 18. 7590318-24-7; 19. 7590318-40-5; 20. 7590318-40-7; 21. 7590319-24-5; 22. 7590319-40-5; 23. 7590440; 24. 7590441; 25. 7590442; 26. 7590443; 27. 7590444; 28. 7590445; 29. 7590446; 30. 7590447; 31. 7590450-5; 32. 7590450-8

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, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Zimbabwe.

Quantity

4,882 units (41950 individual electrode leads supplied In 5,7 & 10 packs)