Recall Z-0315-2024— ROi CPS LLC
Class II · Ongoing
Class II FDA medical device recall by ROi CPS LLC, initiated 2023-09-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit. Reason: Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-21
- Firm location
- Republic, MO, United States
Product description
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Reason for recall
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Data sourced from openFDA. This site is unofficial and independent of the FDA.