Medical device recalls Moderate risk

Arrow International Inc recalls PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, in…

Recall date
July 30, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2462-2015
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
US Nationwide Distribution and internationally to Canada

Why it was recalled

the catheter peel-away component hub tabs may prematurely detach. One injury reported.

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

What was recalled

PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound

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