FDA recall Z-2327-2017

Product

Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

Reason for recall

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Distribution

Worldwide Distribution - US (nationwide) and Canada

Key facts

Status

Terminated

Initiation date

2017-05-09

Report date

2017-06-21

Termination date

2018-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2327-2017