Recall Z-0524-2021— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2020-10-12, terminated 2021-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.. Reason: Labeling error, incorrect expiration date..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-12
- Terminated
- 2021-05-13
- Firm location
- Republic, MO, United States
Product description
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Reason for recall
Labeling error, incorrect expiration date.
Data sourced from openFDA. This site is unofficial and independent of the FDA.