Z-2283-2017 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¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

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 ASK-04001-DU8