Custom Fluid Management Set recalled over mold contamination
- Recall date
- August 12, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Merit Medical Systems, Inc. recalls Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a pati…
- Recall number
- Z-0649-2017
- FDA classification
- Class II
- Brand / firm
- Merit Medical Systems, Inc.
- Sold / distributed
- Nationwide Distribution.
Why it was recalled
Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
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