Class 2 Device Recall Medline Silicone Foley catheter

• Date Initiated by Firm: May 28, 2019
• Create Date: May 18, 2020
• Recall Status: Terminated on January 30, 2023
• Recall Number: Z-2043-2020
• Recall Event ID: 84791
• Product Classification: Catheter, retention type, balloon - Product Code EZL
• Product: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
• Code Information: GTIN 40080196848837 Model DYND11553 lot 287181201.
• Recalling Firm/ Manufacturer: Medline Industries Inc; Three Lakes Drive; Northfield IL 60093
• For Additional Information Contact: Kassandra Cotner; 866-359-1704
• Manufacturer Reason for Recall: Loose silicone particulate was found to be present on the shaft of the silicone catheters.
• FDA Determined Cause: Manufacturing material removal
• Action: Medline Industries, Inc. sent formal letters with response forms to each consignee affected via 1st class mail on May 28, 2019. Each consignee was also provided with a response form to return via fax or email. The recalled product that is will be quarantined at the corporate office located at Three Lakes Drive, Northfield, IL 60093-2753 pending destruction.
• Quantity in Commerce: 0
• Distribution: US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, 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.