Reported Oct 26, 2016 · Terminated

Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation,…

Leonhard Lang Medizintechnik GmbH

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Leonhard Lang Medizintechnik GmbH · Archenweg 56 · Innsbruck, N/A · N/A

Is this the product you have?

  • Skintact Electrodes for Defibrillation, DF29N
  • Product UsageMultifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only
Lot codes and dates
  • 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
Amount recalled
11,110 ( US 8,040; OUS 3,070)

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 26, 2019 · Data as of Sep 19, 5:21 PM UTC

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