FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
- Recall number
- Z-2265-2020
- Recalling firm
- ROi CPS LLC
- Product
- Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
- Status
- Terminated
- Initiated
- 2020-04-20
- Posted
- not on file
- Terminated
- 2020-08-21
- Reason
- Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
- 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
- 40 Kits.
- Distribution
- US nationwide distribution in the states of MO, AR and OK.
- Lot, serial or model codes
- Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FTN
- Firm FEI
- 3014527682
- Firm city
- Republic
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28