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Terminated

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.

FDA Recall Z-2043-2020 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeEZL
Date Initiated2019-05-28
Date Terminated2023-01-30
Product Quantity0

Reason for Recall

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

Firm 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.

Root Cause

Manufacturing material removal

Distribution Pattern

US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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