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Leonhard Lang Gmbh recalls GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. .
Recalled December 31, 2014 · FDA recall Z-0802-2015 · Leonhard Lang
Hazard
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. · FDA Class I
Units
1080 pieces
Sold at
US Nationwide Distribution in the states of OH and TX.
Description
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.
Product
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: 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.
Manufacturer(s)
Leonhard Lang Gmbh
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →