FDA recall Z-1152-2018

Arrow International Inc · Class II · device

Product

ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.

Reason for recall

Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.

Distribution

United States in the state of FL.

Key facts

Status
Terminated
Initiation date
2017-12-21
Report date
2018-03-28
Termination date
2020-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1152-2018