FDA recall Z-2265-2020

ROi CPS LLC · Class II · device

Product

Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

Reason for recall

Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.

Distribution

US nationwide distribution in the states of MO, AR and OK.

Key facts

Status
Terminated
Initiation date
2020-04-20
Report date
2020-06-17
Termination date
2020-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2020