Z-0596-2024 Class I Terminated
FDA device recall Z-0596-2024 was initiated by ROi CPS LLC on Nov 20, 2023 and is designated Class I. Reason for recall: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer. The recall status is terminated (terminated Aug 5, 2024). Affected quantity: 1830 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 10, 2024
- Initiation Date
- Nov 20, 2023
- Termination Date
- Aug 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1830 units
Product Description
Regard Dressing change kit, Item Number 800026006
Reason for Recall
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Distribution Pattern
US Nationwide distribution in the state of Louisiana.
Code Information
UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270