The Recall Desk

FDA (Devices) recall action 67844

Merit Medical Systems, Inc. recalled 2 products on 2014-04-09

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-04-09
Critical
0
Units
95

Why these products were recalled

The products are labeled as sterile but were not sterilized.

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

1–2 of 2

  • HighFDA (Devices)··2014-04-09

    Merit Medical Pressure Monitoring Tubing Recalled for Sterilization Failure

    Merit Medical Systems is recalling 80 units of Pressure Monitoring Tubing PM6006 because the products were labeled as sterile but were not sterilized.

    Product
    Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2014-04-09

    Merit Medical Systems Recalls Non-Sterile Custom Syringe Kits

    Merit Medical Systems is recalling 15 syringe kits labeled as sterile but not sterilized. The products were distributed in the US, Thailand, and Hong Kong.

    Product
    Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
    Category
    Distribution
    1 state