3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Secureme...

FDA Device Recall #Z-1475-2024 — Class II — February 20, 2024

Recall Summary

Recall Number Z-1475-2024
Classification Class II — Moderate risk
Date Initiated February 20, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm 3M Company - Health Care Business
Location Saint Paul, MN
Product Type Devices
Quantity 265,435 eaches

Product Description

3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.

Reason for Recall

Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MN, NC, NH, NY, OH, PA, TX, VA, and WA, including PR. The countries of Australia, Austria, Canada, China, Finland, Germany, Ireland, New Zealand, Norway, Poland, Sweden, and the United Kingdom.

Lot / Code Information

REF 1500U, SKU 70-2011-8908-4, UDI-DI 30707387792405, Lot numbers: 33TNNN: Exp. 2025-11-09; 33TNMH: Exp. 2025-11-08; 33KNWC: Exp. 2024-06-02; 33KNJD: Exp. 2024-06-01; 33KND8: Exp. 2024-05-31. REF 1501U, SKU 70-2011-8924-1, UDI-DI 30707387792399, Lot numbers: 33TNH3: Exp. 2025-11-08; 33TNDC: Exp. 2025-11-07; 33KTDY: Exp. 2024-06-11; 33KWM3: Exp. 2024-06-15; 33KTWT: Exp. 2024-06-13; 33KWHE: Exp. 2024-06-14; 33KTLA: Exp. 2024-06-12; 33KTFP: Exp. 2024-06-11; 33KT9M: Exp. 2024-06-10; 33KP6M: Exp. 2024-06-03.

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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.