Recall Z-0004-2017— Leonhard Lang Medizintechnik GmbH
Class I · Terminated
Class I FDA medical device recall by Leonhard Lang Medizintechnik GmbH, initiated 2016-09-01, terminated 2019-03-26. It names one FDA 510(k) clearance: K142803. 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.. 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..
- Recalling firm
- Leonhard Lang Medizintechnik GmbH
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-09-01
- Terminated
- 2019-03-26
- Firm location
- Innsbruck, N/A, Austria
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.