Recall Z-0004-2017 ยท MKJ Automated External Defibrillators (Non-Wearable)
Leonhard Lang Medizintechnik GmbH
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.
| Date | Oct 14, 2016 (initiated Sep 1, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 t |
| Quantity | 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, South Africa, Lebanon, and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142803 | Skintact, various other tradenames Leonhard Lang GmbH, Dec 2, 2014 |