Device product
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).
Z-1389-2016
Product summary
- Firm
- Cygnus Medical
- Event
- Event 73568
- Status
- Terminated
- Classification
- Class III
- Quantity
- 39 cases of 120 units
- Official record key
device-enforcement:Z-1389-2016
Official wording
Reason: Foreign material in container
Code information: Lot Numbers: EX20170714A and EX201720A
Distribution pattern: US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
Derived failure modes
-
Foreign material or chemical contamination
Foreign material