Skintact Electrode for Defibrillation recalled over sterility concerns

Recall date

August 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Leonhard Lang Medizintechnik GmbH recalls Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for ex…

Recall number

Z-3109-2017

FDA classification

Class I

Brand / firm

Leonhard Lang Medizintechnik GmbH

Sold / distributed

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.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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