Recall Z-0620-2024— ROi CPS LLC
Class I · Terminated
Class I FDA medical device recall by ROi CPS LLC, initiated 2023-12-18, terminated 2024-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: regard Operative LAP, Item Number 800943001; surgical convenience kit. Reason: Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist..
- Recalling firm
- ROi CPS LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2023-12-18
- Terminated
- 2024-10-03
- Firm location
- Republic, MO, United States
Product description
regard Operative LAP, Item Number 800943001; surgical convenience kit
Reason for recall
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Data sourced from openFDA. This site is unofficial and independent of the FDA.