Z-0004-2017Class I

Skintact Electrodes for Defibrillation, DF29N

Name: Z-0004-2017 Skintact Electrodes for Defibrillation, DF29N
Creator: Leonhard Lang Medizintechnik GmbH
Published: 2016-09-01
License: https://open.fda.gov/license/

Leonhard Lang GmbH / initiated 2016-09-01 / Terminated / root cause: design

FDA source

Leonhard Lang Medizintechnik GmbH began a recall of Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The... on 2016-09-01. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0004-2017
Classification: Class I
Status: Terminated
Initiated: 2016-09-01
Posted: 2016-10-14
Terminated: 2019-03-26
Recalling firm: Leonhard Lang GmbH
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: design
FDA 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 to forward a copy of the Safety Notice. For questions contact sales staff.
Quantity in commerce: 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.
Product codes and lots: US: 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 50130-0777; 41023-0771; 41008-0778; 40730-0778; 40618-0778; and, 40130-0776. Outside US: 60725-0774; 60620-0776; 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 40827-0777; 40730-0778; 40618-0778; and, 40130-0776.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0004-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0004-2017	Class I	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-14

Product code MKJ

K142803Class IIISkintact, various other tradenamesLeonhard Lang GmbH / cleared 2014-12-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)