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.
Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the em 2400.
조치
The firm, Baxa, sent a "Exacta-Mix 2400 Compounder Safety Alert" dated June 3, 2008 to all customers. The alert describes the product, problem and actions to be taken. The customers were instructed to not use the main module if any of the 24 valve actuators are damaged; do not infuse any bags if damage is noticed after they have been pumped; do not try to repair or adjust a damaged or bent valve actuator; immediately alert all compounder users of this issue to ensure that when the device is used, the valve actuators are always inspected for damage;" inspect all valve acutators before setup and after tear-down to ensure they are not damaged or bent. Do not use the compounder if the valve actuators are damaged or bent."; and if a damaged or bent valve is noticed after using the EM2400, immediately hold all pumped bags and contact Baxa Technical Support.
If you need additional assistance, please contact Baxa Technical Support (800-678-2292). Technical Support is available 24 hours a day, 7 days a week.
Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, China, New Zealand, and United Kingdom.
제품 설명
The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. || Pharmacy compounding system for mixing ingredients for intravascular administration.