FDAFDA · Food and drugs·Recall number Z-1389-2016
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).
Published April 20, 2016 · Recall initiated: March 17, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Foreign material in container
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cygnus Medical
- Distributor
- US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
- Lot
- Lot Numbers: EX20170714A and EX201720A
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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