Recall Z-1407-2022— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2022-06-03, terminated 2023-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.. Reason: Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-06-03
- Terminated
- 2023-04-14
- Firm location
- Republic, MO, United States
Product description
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Reason for recall
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.