The Recall Desk
HighFDA (Devices)·Z-0004-2017·Announced 2016-10-26

Leonhard Lang Recalls Skintact Defibrillation Electrodes Due to Connection Delay

Leonhard Lang is recalling Skintact DF29N defibrillation electrodes because they may not connect to Welch Allyn AED 10 devices promptly, delaying life-saving treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a malfunction could delay life-saving treatment for patients in life-threatening conditions, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Leonhard Lang Medizintechnik GmbH is recalling Skintact Electrodes for Defibrillation, model DF29N. These multifunction electrodes are used for external defibrillation, pacing, cardioversion, and monitoring. The recall involves 11,110 units distributed worldwide, including in the United States (specifically Florida) and various international locations.

The recall is issued because the electrodes may connect to the Welch Allyn AED 10 defibrillator with delay or not at all. This malfunction creates a risk that a patient in a life-threatening condition requiring a defibrillation shock may not be treated in a timely manner.

Healthcare facilities and distributors should stop using the affected electrodes and contact the manufacturer for instructions on return or replacement. Consumers should not use these specific electrodes with the Welch Allyn AED 10 device.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • 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
  • 40827-0777
  • 40130-0776.

Distribution

Distributed in 1 state:

Same manufacturer · Leonhard Lang Medizintechnik GmbH

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