Medical device recalls Moderate risk

Covidien LLC recalls MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103…

Recall date
August 6, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2535-2015
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 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

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