Z-2262-2017 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
43,394 units

Product Description

Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC 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 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-45552-SPH