Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacin

FDA device recall Z-0004-2017 · posted 2016-10-14 · Terminated

Recall details

Recalling firm

Leonhard Lang Medizintechnik GmbH

Reason for recall

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.

Action taken

Consignees was sent via e-mail a Leonhard Lang "Important Safety Notice" dated September 1, 2016. The letter described the product being recalled, Description of the defect, Actions and time frame of the recall, & Compensation for the recalled electrodes. Advised consignees to inform all users within their organizations of the recall; and, secure and destroy the unused electrodes in their inventory. Confirmation of destruction can be done by completing and returning the "Confirmation of Destruction / Consumption" form by October 14, 2016. If the product was further distributed, they were to forward a copy of the Safety Notice. For questions contact sales staff.

Root cause

Device Design

Status

Terminated

Product code

MKJ

Quantity affected

11,110 ( US 8,040; OUS 3,070)

Distribution

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, Sou

Date initiated

2016-09-01

Date posted

2016-10-14

Date terminated

2019-03-26

Location

Innsbruck, Austria

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