Z-2291-2017 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
March 20, 2017
Termination Date
December 18, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown-firm reports total devices distributed 43,394

Product Description

Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction

Reason for Recall

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Distribution Pattern

Nationwide Distribution

Code Information

Material number CDA-45063-HPK1A