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
Stopcock, i.V. Set - Product Code FMG
원인
Icu is recalling the conmed stat 2 flow controller because it may
deliver a significantly higher flow rate than was intended.
조치
ICU Medical sent an Urgent Medical Device Recall letter dated August 19, 2014 to all affected customers. The letter identified the affected product, problems identified and the actions to be taken. Customers were instructed to complete the recall response form and fax to ICU Medical at (801) 264-1755 or by email: recall@icumed.com. Customers with questions or require assistance relating to this recall were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address:
customerservice@icumed.com.
For questions regarding this recall call 801-264-1732.
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
제품 설명
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.