The Recall Desk
SevereFDA (Devices)·Z-3109-2017·Announced 2017-09-20

Leonhard Lang Skintact Defibrillation Electrodes Recalled for Connection Failure

Leonhard Lang is recalling Skintact defibrillation electrodes that may fail to connect with ZOLL AED PLUS devices, potentially delaying life-saving treatment.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device defect that may prevent life-saving defibrillation in patients with life-threatening conditions, meeting the criteria for significant injury risk or structural defect.

Plain-English summary

Leonhard Lang Medizintechnik GmbH is recalling certain lots of Skintact Electrodes for Defibrillation, Pacing, Monitoring, and Cardioversion. The affected models are DF59N and DF59NC. These multifunction electrodes are non-sterile, single-use devices intended for external defibrillation, pacing, cardioversion, and monitoring, and are used with automated external defibrillators.

The recall is due to a defect where the electrodes may experience a delay in connecting or may not connect at all with the ZOLL AED PLUS defibrillator. This malfunction may prevent a patient in a life-threatening condition from receiving a defibrillation shock in a timely manner.

A total of 8,249 units were distributed worldwide, including in the United States (Florida and Texas) and in Austria, China, France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, United Arab Emirates, and the United Kingdom. Affected lots include DF59N (lot numbers 41219-0778, 50403-0772, 41029-0770) and DF59NC (lot numbers 50211-0974, 50402-0974, 40806-0972, 41203-0973, 50116-0975, 50527-0974) with expiration dates ranging from 09/2017 to 05/31/2018. Users should stop using these specific lots and contact the manufacturer for instructions.

The recalled product

Product
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrilla
Affected units
8,249

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 (9)

  • Model Number DF59N (lot numbers 41219-0778
  • 50403-0772
  • 41029-0770)
  • DF59NC (lot numbers 50211-0974
  • 50402-0974
  • 40806-0972
  • 41203-0973
  • 50116-0975
  • 50527-0974). Expiration date 09/2017 to 05/31/2018.

Distribution

Distributed in 2 states:

Same manufacturer · Leonhard Lang Medizintechnik GmbH

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