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ROi CPS LLC Recall 89875

Description: Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth - Mercy Rogers.

ROi CPS LLC Recall 89875 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1006-2022
Event ID89875
Event DescriptionConvenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth - Mercy Rogers.
Product TypeDevices
DistributionUS Nationwide distribution in the state of Missouri.
Quantity950 convenience kits
Recall ReasonA drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Device Classification20220504
Device Code InfoLot numbers 89889, exp. 5/12/2022; 90446, exp. 5/12/2022; and 90641, exp. 5/12/2022.
Center Classification Date20220426
Recall Initiation Date20220318
Recalling FirmROi CPS LLC
Initial Notification Letter
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