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U.S. Department of Health and Human Services

Class 2 Device Recall Draco Enzymatic DeepCleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

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  Class 2 Device Recall Draco Enzymatic DeepCleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z see related information
Date Initiated by Firm April 17, 2017
Date Posted May 12, 2017
Recall Status1 Terminated 3 on September 21, 2017
Recall Number Z-2211-2017
Recall Event ID 77164
Product Classification Pad, alcohol, device disinfectant - Product Code LKB
Product Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent
Catalogue Number: HY0305Z
Code Information Lot Number: EXP20180616 and EXP20180622
Recalling Firm/
Manufacturer		 Madison Polymeric Engineering
965 W Main St
Branford CT 06405-3453
For Additional Information Contact
800-990-7489
Manufacturer Reason
for Recall		 Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.
FDA Determined
Cause 2		 Other
Action Cygnus Medical sent a first class letter dated April 14, 2017, indicating to discontinue use of HY0305Z Draco Pads with information to return the unused product also included. Our records indicate that you have purchased this lot number. Please check your inventory. The lot number can be found on the individual product pouch and the label on the carton. We have found a mold contaminant and request that you remove the product from use and return to us. We are conducting an investigation. To obtain a return authorization please contact our Quality Department. You may also contact our customer service at (800) 990-7489. We regret any inconvenience this may cause. Please contact Cygnus Medical LLC should you have any questions.
Quantity in Commerce 5 cases
Distribution Distributed in the US.
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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