Z-2292-2017 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

"Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the 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 CDC-41541-JX1A