Recall Z-1408-2022— 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 kit: regard Item #830014016, LD00199P - C Section Mother.. 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 kit: regard Item #830014016, LD00199P - C Section Mother.
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.