Recall Z-2265-2020— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2020-04-20, terminated 2020-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.. Reason: Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-20
- Terminated
- 2020-08-21
- Firm location
- Republic, MO, United States
Product description
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Reason for recall
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Data sourced from openFDA. This site is unofficial and independent of the FDA.