FDA recall Z-0252-2022
ROi CPS LLC · Class II · device
Product
REGARD Ear Tray
Reason for recall
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Distribution
US Nationwide in the states of FL, LA and MO.
Key facts
- Status
- Terminated
- Initiation date
- 2021-08-10
- Report date
- 2021-11-24
- Termination date
- 2023-06-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Republic, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0252-2022