FDA recall Z-3109-2017

Product

Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators

Reason for recall

Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.

Distribution

Worldwide distribution. US distribution in the states of : FL & TX. Austria, China, France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom.

Key facts

Status

Terminated

Initiation date

2017-08-08

Report date

2017-09-20

Termination date

2020-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Innsbruck, N/A, Austria

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3109-2017