The Recall Desk
ModerateFDA (Devices)·Z-1475-2024·Announced 2024-04-10

3M Tube Securement Devices Recalled for Missing Film Layer and Shape Defects

3M is recalling 265,435 tube securement devices (REF 1500U and 1501U) due to manufacturing defects including missing or partial top film layers and incorrect device shape from excess material not properly removed.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II medical device recall involving manufacturing nonconformities with no reported adverse events, injuries, or hospitalizations. The defects are precautionary in nature and managed as a Class II recall without evidence of clinical harm.

Plain-English summary

3M Company is recalling 265,435 units of Tube Securement Devices (Models 1500U and 1501U, in Small 1.7 IN/PO x 2.4 IN/PO and Large 2.2 IN/PO x 3.5 IN/PO configurations) due to manufacturing nonconformities identified in certain production lots.

The manufacturing defects include top film layers that may be partially or completely missing from the device packaging, and some devices may exhibit incorrect shape due to excess material not being properly removed from the product liner. These defects could affect the ability of the devices to properly secure medical tubing.

The recalled devices were distributed worldwide. In the United States, distribution occurred in California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Texas, Virginia, Washington, and Puerto Rico. International distribution includes Australia, Austria, Canada, China, Finland, Germany, Ireland, New Zealand, Norway, Poland, Sweden, and the United Kingdom.

The recalled product

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.
Manufacturer
3M Company - Health Care Business
Category
Medical Device — Tube Securement Device
Hazard
  • film-layer-missing
  • shape-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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.

Distribution

Distributed nationwide across the United States.

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