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.
The trio monitor has latex feet. it is not labeled per 21 cfr801.437 to indicate that it contains latex.
조치
On July 28, 2004, the firm sent out a Urgent Product Field Correction via FedEx to their customers. Enclosed with this letter was the replacement feet, an Instruction form and a field correction completion form.