Drug recall
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external…
FDA recall event 75181 · Class I · Leonhard Lang Medizintechnik GmbH
Key facts
| Event ID | 75181 |
|---|---|
| Recall numbers | Z-0004-2017 |
| Recalling firm | Leonhard Lang Medizintechnik GmbH |
| Product type | Devices |
| 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 1, 2016 |
| Report date | Oct 26, 2016 |
| Termination date | Mar 26, 2019 |
| City | Innsbruck |
| Country | Austria |
| FEI number | 6736 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: