FDA recall Z-2332-2017

Product

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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-2332-2017