Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
US Nationwide distribution in the state of Missouri.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1004-2022