Class 2 Device Recall Draco

• Date Initiated by Firm: May 08, 2019
• Create Date: July 02, 2019
• Recall Status: Terminated on July 06, 2020
• Recall Number: Z-1924-2019
• Recall Event ID: 82971
• Product Classification: Accessories, cleaning brushes, for endoscope - Product Code MNL
• Product: Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
• Code Information: Lot Numbers EX20191121P EX20191126P EX20191127P EX20191212X EX20191213X EX20200125X
• FEI Number: 3001451466
• Recalling Firm/ Manufacturer: Madison Polymeric Engineering; 965 W Main St; Branford CT 06405-3453
• For Additional Information Contact: Cathey Szeto; 203-488-4554
• Manufacturer Reason for Recall: This product has been contaminated with Stenotrophomonas lactiubi.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall notification letters dated 5/8/19 were sent to customers.
• Quantity in Commerce: 2723
• Distribution: The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.
• 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.