The Recall Desk

FDA (Devices) recall action 92466

MEDLINE INDUSTRIES, LP - Northfield recalled 52 products on 2023-07-26

The FDA (Devices) publishes a recall like this one as 52 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 52 pages.

Products
52
Announced
2023-07-26
Critical
0
Units
37,040,410

Why these products were recalled

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

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.

51–52 of 52

  • HighFDA (Devices)··2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline has recalled approximately 3.7 million ultrasound probe cover kits due to inadequate barriers at the seams that could affect sterile field integrity during diagnostic procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS,
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-07-26

    Medline Probe Cover Kits: Inadequate Seam Barrier Risk

    Medline probe cover kits used in ultrasound-guided medical procedures may have inadequate barriers at the seams, posing a contamination risk. Approximately 270,000 units distributed worldwide since December 2017 are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number
    Category
    Distribution
    0 states