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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Silicone Foley catheter

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  Class 2 Device Recall Medline Silicone Foley catheter see related information
Date Initiated by Firm May 28, 2019
Create Date May 18, 2020
Recall Status1 Terminated 3 on January 30, 2023
Recall Number Z-2042-2020
Recall Event ID 84791
510(K)Number K142635  
Product Classification Catheter, retention type, balloon - Product Code EZL
Product SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 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 40884389034416 Model DYND11552 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 2		 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 330
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.
510(K) Database 510(K)s with Product Code = EZL and Original Applicant = MEDLINE INDUSTRIES, INC.
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