FDA-Device2017-06-21Class II

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

Arrow International Inc
Hazard

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Sold states
Worldwide Distribution - US (nationwide) and Canada
Affected count
27,485 units distributed in U.S., 4,371 units distributed internationally
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2017

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