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 |
| Similar To |