The Recall Desk

FDA (Devices) recall action 74892

Zyno Medical LLC recalled 4 products on 2016-10-05

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-10-05
Critical
0
Units
318,202

Why these products were recalled

Administration Set potential filter leaking

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.

1–4 of 4

  • HighFDA (Devices)··2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 78,069 sterile administration sets because the filter may leak. The sets are used to administer fluids to patients.

    Product
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 78,063 sterile administration sets due to a potential filter leaking defect. The sets are distributed nationwide for use with infusion pumps or gravity feed.

    Product
    Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a conta
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 114,081 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients' vascular systems.

    Product
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a contai
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 47,989 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients.

    Product
    Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
    Category
    Distribution
    0 states