ROi CPS LLC Recall 89875
Description: Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother - Joplin; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother - Lebanon.
ROi CPS LLC Recall 89875 Information
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1005-2022 |
Event ID | 89875 |
Event Description | Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother - Joplin; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother - Lebanon. |
Product Type | Devices |
Distribution | US Nationwide distribution in the state of Missouri. |
Quantity | 1,501 convenience kits |
Recall Reason | 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. |
Device Classification | 20220504 |
Device Code Info | (1) Item Number: 830015013 - Lot numbers 87230M, exp. 5/31/2022; 87954M, exp. 5/31/2022; 88285M, exp. 5/31/2022; 88999M, exp. 6/30/2022; 89494, exp. 5/31/2022; 89985, exp. 6/30/2022; 90866, exp. 6/30/2022; and 91603, exp. 5/31/2023; and (2) Item 830084003 - Lot numbers 86155C, exp. 3/31/2022; 84799C, exp. 3/31/2022; 86735C. exp. 3/31/2022, 87269C, exp. 7/31/2022; 87871C, exp. 7/31/2022; 88564C, exp. 1/31/2023; 89260, exp. 2/28/2023; 89820, exp. 2/28/2023; 90253, exp. 1/31/2023; 90594, exp. 12/31/2022; and 91335, exp. 12/31/2022. |
Center Classification Date | 20220426 |
Recall Initiation Date | 20220318 |
Recalling Firm | ROi CPS LLC |
Initial Notification | Letter |
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