Z-2265-2020Class II

Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy

Name: Z-2265-2020 Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy
Creator: ROi CPS LLC
Published: 2020-04-20
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2020-04-20 / Terminated

FDA source

ROi CPS LLC began a recall of Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy on 2020-04-20. FDA classified it as Class II and gives the reason as "Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2265-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-20
Posted: 2020-06-05
Terminated: 2020-08-21
Recalling firm: ROi CPS LLC
Product: Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Product code: FTN Plastic Surgery And Accessories Kit
Reason for recall: Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
FDA root cause: Other
Action: 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.
Quantity in commerce: 40 Kits.
Distribution: US nationwide distribution in the states of MO, AR and OK.
Product codes and lots: Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2265-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2265-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-05

Product code FTN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)