Class 2 Device Recall Draco Enzymatic DeepCleaning Pad

• Date Initiated by Firm: March 21, 2018
• Create Date: May 18, 2018
• Recall Status: Terminated on April 09, 2019
• Recall Number: Z-1900-2018
• Recall Event ID: 79826
• Product Classification: Accessories, cleaning brushes, for endoscope - Product Code MNL
• Product: Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
• Code Information: Lot Numbers: EX20181226P, EX20181227P, EX20181228P, EX20181229P, EX20190102P
• Recalling Firm/ Manufacturer: Madison Polymeric Engineering; 965 W Main St; Branford CT 06405-3453
• For Additional Information Contact: Cathey Szeto; 203-488-4554 Ext. 105
• Manufacturer Reason for Recall: The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
• FDA Determined Cause: Under Investigation by firm
• Action: Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following: 1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1. 2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us. 3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.
• Quantity in Commerce: 13 cases/1300 pads
• Distribution: The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
• 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.