FDA recall Z-0658-2018

Product

ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; 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-0658-2018