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.
Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707f (with female luer lock connectors).
조치
The firm notified the three affected customers directly by phone, followed by a recall form for each direct customer indicating the product, part number, lot number and shipment date and customer order specific for each firm. Customers were to complete and return the form to the fax number listed or call a Customer Service Representative at 1-800-628-4690.
ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. || Salter Labs Nasal Cannula (Adult), Salter Style || with modified nasal prongs. || w/7' O2 line and 7' CO2 line with male luer lock connector. || Salter Labs || 100 W. Sycamore Road, || Arvin, CA 93203