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Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Recalled March 29, 2017 · FDA recall Z-1484-2017 · Vygon MFG, Inc., dba/ Churchill Medical Systems
Hazard
Incorrect priming volume printed on the device package. · FDA Class II
Units
30,700
Sold at
US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
Description
Incorrect priming volume printed on the device package.
Product
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Manufacturer(s)
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →