—#179413

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.

FDA product code: EZL — Catheter, Retention Type, Balloon
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K142635
Affected lot / code info: GTIN 40884389034416 Model DYND11552 lot 287181201.

Why it was recalled

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

Root cause (FDA determination)

Manufacturing material removal

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

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

Timeline

Recall initiated: 2019-05-28
Terminated: 2023-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179413. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.