Events

Recall of Device Recall First Step Bedside ADDWATER kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cygnus Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73568
  • Event Risk Class
    Class 3
  • Event Number
    Z-1389-2016
  • Event Initiated Date
    2016-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144479
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories, cleaning brushes, for endoscope - Product Code MNL
  • Reason
    Foreign material in container.
  • Action
    Cygnus Medical LLC sent an Recall Notice letter certified mail to direct customers and receivers on March 17, 2016. The letter identified the product the problem and the action needed to be taken by the customer. The letter was preceded with an email or fax to expedite notification. Customers to respond via fax or email regarding the quantities in their possession, including a response where the quantity is zero. Returns to made to firm. Contact Quality Manager Cygnus Medical LLC, phone: (203) 488-4554 x 105 fax: (203) 764-1858.Email: qualitycontrol@madpoly.com. For further questions, please call (203) 488-4554.

Device

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

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