Z-1475-2024Class II

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

Name: Z-1475-2024 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device...
Creator: 3M Company - Health Care Business
Published: 2024-02-20
License: https://open.fda.gov/license/

3M Company / initiated 2024-02-20 / Open, Classified / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 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... on 2024-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1475-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-20
Posted: 2024-04-03
Recalling firm: 3M Company
Product: 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.
Product code: KGX Tape And Bandage, Adhesive
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 265,435 eaches
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1475-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1475-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03

Product code KGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)