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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