FDA-Device2022-05-04Class II
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
ROi CPS LLC
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.
Sold states
US Nationwide distribution in the state of Missouri.
Affected count
950 convenience kits
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1006-2022Don't want to check this manually?
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