FDA recall Z-2331-2017

Product

1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring

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-2331-2017