The Recall Desk

FDA (Devices) recall action 84791

Medline Industries Inc recalled 3 products on 2020-05-27

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
2020-05-27
Critical
0
Units
330

Why these products were recalled

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

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

  • HighFDA (Devices)··2020-05-27

    Medline Silicone Foley Catheters Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling 330 units of 100% Silicone Foley Catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2020-05-27

    Medline Silicone Foley Catheter Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2020-05-27

    Medline Recalls Silicone Foley Catheters Due to Loose Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Distribution
    11 states