Medical device recalls Moderate risk

Arrow International Inc recalls 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard A…

Recall date
May 9, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2331-2017
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
Worldwide Distribution - US (nationwide) and Canada

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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