Home / Recalls / Medical Devices
Leonhard Lang Medizintechnik GmbH recalls Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, p
Recalled October 26, 2016 · FDA recall Z-0004-2017 · Leonhard Lang Medizintechnik
Hazard
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. · FDA Class I
Units
11,110 ( US 8,040; OUS 3,070)
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Leonhard Lang Medizintechnik GmbH
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →