Recall Z-1051-2022— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2022-03-21, terminated 2023-12-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard brand CABG Pack A and B - Spartanburg. Reason: Kits were packed into shipping boxes incorrectly..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-21
- Terminated
- 2023-12-28
- Firm location
- Republic, MO, United States
Product description
Regard brand CABG Pack A and B - Spartanburg
Reason for recall
Kits were packed into shipping boxes incorrectly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.