FDA-Device2016-10-26Class I
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.
Leonhard Lang Medizintechnik GmbH
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.
Sold states
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.
Affected count
11,110 ( US 8,040; OUS 3,070)
Manufactured in
Archenweg 56, N/A, Innsbruck, N/A, Austria
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2017Don't want to check this manually?
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