ROi CPS LLC Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
Products Sold
Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
ROi CPS LLC is recalling Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. due to Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026