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Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used
Recalled December 28, 2016 · FDA recall Z-0787-2017 · Vygon MFG, Inc., dba/ Churchill Medical Systems
Hazard
Incorrect priming volume is printed on the device package. · FDA Class II
Units
31,500
Sold at
US distribution in the state of CA
Description
Incorrect priming volume is printed on the device package.
Product
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 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 →