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ROi CPS LLC recalls Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD
Recalled May 4, 2022 · FDA recall Z-1005-2022 · ROi CPS
Hazard
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. · FDA Class II
Units
1,501 convenience kits
Sold at
US Nationwide distribution in the state of Missouri.
Description
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.
Product
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
Manufacturer(s)
ROi CPS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →