Medical device recalls Moderate risk

Smiths Medical ASD Inc. recalls CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set…

Recall date
May 15, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2589-2017
FDA classification
Class II
Brand / firm
Smiths Medical ASD Inc.
Sold / distributed
US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY.

Why it was recalled

One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.

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

What was recalled

CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set is designed for use with the CADD¿ Prizm pump to allow fluid deliver from an IV bag.

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