Medical device recalls Moderate risk

Covidien LLC recalls Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm It…

Recall date
August 6, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2526-2015
FDA classification
Class II
Brand / firm
Covidien LLC
Sold / distributed
US Nationwide Distribution

Why it was recalled

Sterility may be compromised

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

What was recalled

Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

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