FDA-Device2016-04-20Class III
Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
Cygnus Medical
Hazard
Foreign material in container
Sold states
US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
Affected count
39 cases of 120 units
Manufactured in
965 W Main St, N/A, Branford, CT, United States
Products
Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2016Don't want to check this manually?
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