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
Multi-Function Electrocardiograph Electrode - Product Code MLN
원인
The "leads out" connector had bent pins which would not allow connection to the medtronic physio control defibrillator cable during a product demonstration.
조치
The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information.
Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.