Recall Z-2265-2020
ROi CPS LLC · initiated April 20, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Codes / lots: Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
Reason for recall
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2265-2020
- Initiated
- April 20, 2020
- Terminated
- August 21, 2020
- Product code
- FTN – Plastic Surgery And Accessories Kit
- Quantity
- 40 Kits.
- Distribution
- US nationwide distribution in the states of MO, AR and OK.
- Recalling firm
- ROi CPS LLC, Republic, MO