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U.S. Department of Health and Human Services

Class 3 Device Recall First Step Bedside ADDWATER kit

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  Class 3 Device Recall First Step Bedside ADDWATER kit see related information
Date Initiated by Firm March 17, 2016
Create Date April 14, 2016
Recall Status1 Terminated 3 on May 23, 2016
Recall Number Z-1389-2016
Recall Event ID 73568
Product Classification Accessories, cleaning brushes, for endoscope - Product Code MNL
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).
Code Information Lot Numbers: EX20170714A and EX201720A 
Recalling Firm/
Manufacturer		 Cygnus Medical
965 W Main St
Branford CT 06405-3431
Manufacturer Reason
for Recall		 Foreign material in container
FDA Determined
Cause 2		 Packaging
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.
Quantity in Commerce 39 cases of 120 units
Distribution US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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