FDA recall Z-0653-2018

Arrow International Inc · Class II · device

Product

Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018

Reason for recall

These finished good kits may contain the incorrect Springwire Guide (SWG).

Distribution

Distribution US Nationwide

Key facts

Status
Terminated
Initiation date
2017-10-17
Report date
2018-02-28
Termination date
2020-04-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0653-2018