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).
FDA Recall Z-1389-2016 · Posted None
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Recalling FirmCygnus Medical
Recall StatusTerminated
Product CodeMNL
Date Initiated2016-03-17
Date Terminated2016-05-23
Product Quantity39 cases of 120 units
Reason for Recall
Foreign material in container
Firm 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: [email protected].
For further questions, please call (203) 488-4554.
Root Cause
Packaging
Distribution Pattern
US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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