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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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 threatening condition and…"
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.
- Manufacturer
- Leonhard Lang Medizintechnik GmbH
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:
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