Device product
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Z-0524-2021
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 86626
- Status
- Terminated
- Classification
- Class II
- Quantity
- 220 kits
- Official record key
device-enforcement:Z-0524-2021
Official wording
Reason: Labeling error, incorrect expiration date.
Code information: Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C.
Distribution pattern: US Nationwide distribution in the states of MO and OK.
Derived failure modes
-
Labeling or packaging
Labeling error, incorrect