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
unknown device name - Product Code CAJ
원인
Inadequate warning label: medex has determined that it is possible for an extracorporeal membrane oxygenation (ecmo) circuit to generate high negative pressures on the inlet side.
조치
Consignees were notified by letter starting 2/2004 and continues to the present
Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump for use with 1cc to 60cc syringes), 3010aZE (Refurbished pump for use with 1cc to 60cc syringes), 3010E (Pump for use with 3-60cc used in the UK), 3010SD (Model 3010 pump used for demonstrations), 3010VX (Evaluation pump for use with 3-60cc syringes), 3010E, 3500 (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits), 3500BC (Not currently in distribution, 3500E (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits used I the UK), 3500G (Pump with face plates and software for rapid occlusion detection and upper and lower programmable infusion dose limits in the German language), 3500SD (Model 3500 pump used for demonstrations, 3500VX (Evaluation pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits.