Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM… recallZ-2265-2020 · ROi CPS LLC · initiated Apr 20, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
FDA root cause category: Other
What the company is doing
ROi CPS, LLC notified customer on 04/23/2020 via "Urgent Medical Device Recall Notice" The recall letter identified the affected product requested the users to review their inventory and quarantine the affected lots. The consignees were asked to complete and return the recall form.
Recall details
- Recall number
- Z-2265-2020
- Status
- Terminated
- Initiated by the company
- Apr 20, 2020
- Recalling firm
- ROi CPS LLC
- Quantity
- 40 Kits.
- Product code
- FTN
- Distribution
- US nationwide distribution in the states of MO, AR and OK.
Product description
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Code information (models, lots, serial numbers)
Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ GS0348Resource Optimization & Innovation, L.L.C. · Port Introducer Kit1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page