3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO… recallZ-1475-2024 · 3M Company - Health Care Business · initiated Feb 20, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3M Company - Health Care Business or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
The recalling firm issued letters addressed to either the distributor, health care customer, or retailer dated 2/14/2024 via email or certified mail on 2/20/2024. The distributor letter explained the issue and provided the affected lot numbers with photographs embedded in the letter to illustrate where to find the model numbers and lot numbers that were affected. The distributors were to immediately discontinue distribution of the affected products and quarantine them for destruction. They were to complete the Distributor Acknowledgement Form to acknowledge they have read and understand the letter, to report if they have affected product in stock and have destroyed them per facility policy, and to email the completed form back to the recalling firm. The distributor is to notify any of their customers who have purchased the affected products using the enclosed Customer Letter dated 2/14/2024 and the Customer Acknowledgement Form. The customer letter enclosed with the distributor letter was similar to the distributor letter except it instructed them to contact the distributor for the next steps on requesting credit for the affected products before destruction and to complete the Customer Acknowledgement Form. The letter for the health care customer was similar to the distributor letter but it did not contain instructions to notify customers who were distributed the affected product. It did request the health care customer to ensure the notice was passed to all who need to be aware within their organization or to any department where the affected product has been transferred.
Recall details
- Recall number
- Z-1475-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2024
- Posted by the FDA
- Apr 3, 2024
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 265,435 eaches
- Product code
- KGX
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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