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U.S. Department of Health and Human Services

Class 2 Device Recall Draco Enzymatic DeepCleaning Pads

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  Class 2 Device Recall Draco Enzymatic DeepCleaning Pads see related information
Date Initiated by Firm December 14, 2018
Create Date February 28, 2019
Recall Status1 Terminated 3 on December 31, 2019
Recall Number Z-0969-2019
Recall Event ID 81971
Product Classification Accessories, cleaning brushes, for endoscope - Product Code MNL
Product Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z

Product Usage:
Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neutral pH. Safe to use on all surgical instruments, flexible endoscopes and probes.
Code Information Lot numbers: EX20190419P EX20190420P EX20190423P EX20190424P
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 product is contaminated with Pseudomonas.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Cygnus sent an Urgent Medical Device Recall notification letters dated December 14, 2018 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 800-990-7489.
Quantity in Commerce 4800 pads
Distribution Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: 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.
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