FDA recall Z-0524-2021
ROi CPS LLC · Class II · device
Product
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Reason for recall
Labeling error, incorrect expiration date.
Distribution
US Nationwide distribution in the states of MO and OK.
Key facts
- Status
- Terminated
- Initiation date
- 2020-10-12
- Report date
- 2020-12-09
- Termination date
- 2021-05-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0524-2021