Medical device recalls Moderate risk

Arrow International Inc recalls ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral a…

Recall date
June 1, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0181-2018
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

Why it was 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.

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

What 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

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