Device product
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Z-2265-2020
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 85591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 Kits.
- Official record key
device-enforcement:Z-2265-2020
Official wording
Reason: Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
Code information: Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
Distribution pattern: US nationwide distribution in the states of MO, AR and OK.
Derived failure modes
-
Unknown
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.