Reported Dec 31, 2014 · Terminated
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. .…
Leonhard Lang 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 Gmbh · Archenweg 56 · Innsbruck · N/A
Is this the product you have?
- GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005
- Product UsageUsage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only
- Lot codes and dates
- Lots
30618-077130702-077840217-077640407-077740424-077240704-0775
- Lots
- Amount recalled
- 1080 pieces
Where it was sold
Why it was recalled
Stop using this product now
The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.
Using this product could cause serious injury, illness or death — stop using it now.
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