Z-0802-2015 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- December 3, 2014
- Termination Date
- August 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1080 pieces
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution in the states of OH and TX.
Code Information
Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775