FDA recall Z-0649-2018

Arrow International Inc · Class II · device

Product

Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; 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-0649-2018