Skintact Electrodes for Defibrillation recalled over sterility concerns

Recall date

September 1, 2016

Source

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

Official notice title

Leonhard Lang Medizintechnik GmbH recalls Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, paci…

Recall number

Z-0004-2017

FDA classification

Class I

Brand / firm

Leonhard Lang Medizintechnik GmbH

Sold / distributed

Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland.

Why it was recalled

There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. 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 Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.