Reported Sep 20, 2017 · Terminated
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for…
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 Electrode for Defibrillation, Pacing, Monitoring, Cardioversion
- Product UsageMultifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators
- Lot codes and dates
- 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.
- Amount recalled
- 8,249 units total
Where it was sold
Why it was recalled
Stop using this product now
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. 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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