Recall Z-2265-2020 ยท FTN Plastic Surgery And Accessories Kit
ROi CPS LLC
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
| Date | Apr 20, 2020 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.