Cygnus Medical First StepBedside ADDWATER Kit recalled over foreign material

Recall date

March 17, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cygnus Medical recalls Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The…

Recall number

Z-1389-2016

FDA classification

Class III

Brand / firm

Cygnus Medical

Sold / distributed

US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.

Why it was recalled

Foreign material in container

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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).