Recall Z-0596-2024— ROi CPS LLC
Class I · Terminated
Class I FDA medical device recall by ROi CPS LLC, initiated 2023-11-20, terminated 2024-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard Dressing change kit, Item Number 800026006. Reason: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer..
- Recalling firm
- ROi CPS LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2023-11-20
- Terminated
- 2024-08-05
- Firm location
- Republic, MO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.