FDA-Device2016-12-28Class II
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Hazard
Incorrect priming volume is printed on the device package.
Sold states
US distribution in the state of CA
Affected count
31,500
Manufactured in
87 Venture Dr, N/A, Dover, NH, United States
Products
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0787-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief