Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators

• 2 recalls, same reason

  • Terminated Z-2234-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2009
  • Terminated Z-2233-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2009

  A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. In such cases increased force or some wiggling is required to insert the connector fully. A potential risk for patients exist, if (a) such a connector (b)

510(k) Number

K072233 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Skintact

  Class I

  CE/MDR

• megro

  Class I

  CE/MDR

• Skintact and Various Other Tradenames

  Class II

  FDA 510(k) K073104 Active Cleared 16 Nov 2007

• Skintact Radiotransparent Multifunction Electrodes

  Class III

  FDA 510(k) K103186 Active Cleared 8 Feb 2011

• Skintact Multifunction Electrodes, Model DF 21

  Class III

  FDA 510(k) K041883 Active Cleared 7 Sep 2004

• Skintact ECG Electrode

  Class II

  FDA 510(k) K040249 Active Cleared 24 Feb 2004

See all devices from Leonhard Lang GmbH →

• Are these electrodes reusable or intended for single-use only, and how should they be handled after use?

  The Skintact Multifunctional Electrodes are designed for single-use only. Since they are pre-gelled with DH02 gel and adhesive, they should be discarded after a single application to maintain sterility and ensure safe, reliable performance. Proper disposal follows standard single-use medical device protocols, as no reuse is recommended or supported by the manufacturer.

• What types of defibrillators are these electrodes compatible with, and how do I confirm compatibility with my specific device?

  These electrodes are engineered to work with multiple automated external defibrillators (non-wearable) and include multiple connector types to ensure broad compatibility. The listed FDA registration numbers (e.g., 3026976873, 1218058, etc.) correspond to defibrillator models they are cleared for. To confirm compatibility with your device, cross-reference your defibrillator’s model number against the provided registration numbers or consult Leonhard Lang GmbH’s documentation.

• How should I store these electrodes, and are there any special handling instructions before use?

  The electrodes should be stored following standard single-use medical device protocols, which typically include keeping them in a clean, dry environment away from direct sunlight or extreme temperatures. Since they are pre-gelled and adhesive, ensure the packaging remains intact until use to preserve sterility and functionality. No MRI safety considerations are specified, so standard storage practices apply.

• What sizes or models of these electrodes are available, and how do I determine the correct size for a patient?

  The provided data does not specify exact sizes or model variants of the Skintact electrodes beyond their multifunctional design. However, they are designed for adult chest application in out-of-hospital cardiac arrest scenarios. Sizing is typically determined by the defibrillator’s electrode placement guidelines, which may vary by manufacturer. For precise sizing guidance, refer to the defibrillator’s user manual or consult Leonhard Lang GmbH’s support resources.