PlainRecalls
FDA Devices Moderate Class II Terminated

1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC 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

Reported: June 21, 2017 Initiated: May 9, 2017 #Z-2331-2017

Product Description

1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC 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 is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Details

Recalling Firm
Arrow International Inc
Units Affected
27,485 units distributed in U.S., 4,371 units distributed internationally
Distribution
Worldwide Distribution - US (nationwide) and Canada
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC 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. Recalled by Arrow International Inc. Units affected: 27,485 units distributed in U.S., 4,371 units distributed internationally.
Why was this product recalled?
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2331-2017.