Device product
Regard Dressing change kit, Item Number 800026006
Z-0596-2024
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 93525
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1830 units
- Official record key
device-enforcement:Z-0596-2024
Official wording
Reason: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Code information: UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
Distribution pattern: US Nationwide distribution in the state of Louisiana.
Derived failure modes
-
Unknown
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.