Devices

Device Recall First Step Bedside ADDWATER kit

Model / Serial
Lot Numbers: EX20170714A and EX201720A
Product Classification
Gastroenterology-Urology Devices
Device Class
1
Implanted device?
No
Distribution
US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
Product Description
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).
Manufacturer
Cygnus Medical
1 Event
- Recall of Device Recall First Step Bedside ADDWATER kit

Manufacturer

Cygnus Medical

Manufacturer Address
Cygnus Medical, 965 W Main St, Branford CT 06405-3431
Manufacturer Parent Company (2017)
Cygnus Medical L.L.C.
Source
USFDA

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