Z-1475-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2024
- Initiation Date
- February 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
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.