3M Company - Health Care Business: 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

Hazard

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.

Details from the source

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: 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. Quantity: 265,435 eaches Lot/code info: 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.

UPC codes

30707387792405, 30707387792399

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.