PlainRecalls
FDA Devices Moderate Class II Terminated

ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Reported: December 6, 2017 Initiated: June 1, 2017 #Z-0180-2018

Product Description

ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Reason for Recall

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Details

Recalling Firm
Arrow International Inc
Units Affected
N/A
Distribution
Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. Recalled by Arrow International Inc. Units affected: N/A.
Why was this product recalled?
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 6, 2017. Severity: Moderate. Recall number: Z-0180-2018.