SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Fo...

FDA Device Recall #Z-2043-2020 — Class II — May 28, 2019

Recall Summary

Recall Number Z-2043-2020
Classification Class II — Moderate risk
Date Initiated May 28, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries Inc
Location Northfield, IL
Product Type Devices

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Lot / Code Information

GTIN 40080196848837 Model DYND11553 lot 287181201.

Other Recalls from Medline Industries Inc

Recall # Classification Product Date
Z-0358-2022 Class II EVLP Convenience Pack/Kit Oct 27, 2021
Z-0360-2022 Class II Major Vascular CDS Convenience Kit Oct 27, 2021
Z-0359-2022 Class II Neuro Convenience Kit Oct 27, 2021
Z-0362-2022 Class II Bedside PICC CDS Convenience Kit Oct 27, 2021
Z-0361-2022 Class II Venous Access Pack-LF Convenience Kit Oct 27, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.