Recall Z-1542-2021— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2021-03-26, terminated 2023-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard Dressing Change Tray. Reason: ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-26
- Terminated
- 2023-01-30
- Firm location
- Republic, MO, United States
Product description
Regard Dressing Change Tray
Reason for recall
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.