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.
Icu has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
조치
ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned.
For questions regarding this recall call 801-264-1732.
Worldwide Distribution - USA including Oregon and Internationally to Australia.
제품 설명
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 || Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.