Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
- Recall date
- February 20, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1484-2017
- FDA classification
- Class II
- Brand / firm
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- Sold / distributed
- US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
Why it was recalled
Incorrect priming volume printed on the device package.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
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