FDA-Device2017-03-29Class II
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Hazard
Incorrect priming volume printed on the device package.
Sold states
US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
Affected count
30,700
Manufactured in
87 Venture Dr, Dover, NH, United States
Products
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2017Don't want to check this manually?
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