FDA recall Z-2328-2017

Product

Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation

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-2328-2017