Z-1389-2016 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2016
- Initiation Date
- March 17, 2016
- Termination Date
- May 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 cases of 120 units
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).
Reason for Recall
Foreign material in container
Distribution Pattern
US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
Code Information
Lot Numbers: EX20170714A and EX201720A