CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non recalled
ROi CPS is recalling Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non, distributed nationwide in the US. The recall was initiated on 20 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2265-2020
- FDA event ID
- 85591
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2020
- FDA classified
- 5 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Apr 2020 | Recall initiated by company | |
| 5 Jun 2020 | Classified by FDA | +46 days |
| 17 Jun 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Product as listed by the FDA
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Where it was distributed
US nationwide distribution in the states of MO, AR and OK.
Questions about this recall
Why was it recalled?
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Which lots are affected?
Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
Where was it sold?
US nationwide distribution in the states of MO, AR and OK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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