FDA recall Z-0950-2022
Resource Optimization & Innovation LLC · Class II · device
Product
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Reason for recall
A kit component, the PDI Prevantics Swab, was recalled.
Distribution
US distribution to two consignees located in Missouri
Key facts
- Status
- Terminated
- Initiation date
- 2022-02-28
- Report date
- 2022-04-27
- Termination date
- 2022-05-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Saint Louis, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0950-2022