The Recall Desk

FDA (Devices) recall action 93327

MEDLINE INDUSTRIES, LP - Northfield recalled 3 products on 2024-01-03

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2024-01-03
Critical
0
Units
621,457

Why these products were recalled

The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Devices)··2024-01-03

    Medline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment

    Medline is recalling 620,735 tracheostomy care kits because the brush component has a sharp edge that can puncture tubing and injure users, and bristles can detach during use.

    Product
    Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile; (4) Medli
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-01-03

    Medline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect

    Medline is recalling 172 Nursing Skills kits due to defects in the tracheostomy brush component. The brush has a sharp edge that can puncture tubing and cause user injury, and bristles may detach during use.

    Product
    (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-01-03

    Medline Nurse Training Kits Recalled for Sharp Tracheostomy Brush

    Medline Industries recalls 550 educational nurse training kits due to sharp edges on tracheostomy brush components that can puncture tubing or cause injury, and bristles that may detach during or before use.

    Product
    (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
    Category
    Distribution
    1 state