U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Electrode, electrodcardiograph, multi-function - Product Code MLN
원인
Multi-function electrode programmed as a pediatric instead of adult.
조치
Bio-Deteck notified the own label distributor and in cooperation the firm notified their customers by letter dated 6/16/08. Users are requested to return the lots and replacement product will be provided.
Zoll issued and Urgent Device Correction letter on June 16, 2008 with instructions to follow if the device is used with the defective electrodes. If you have questions, contact ZOLL Medical Technical Service at 1-800-348-9011.
ZOLL OneStep Multi-Function Electrode; Adult Complete || Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.