FDA (Devices) recall action 75367
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
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.
Merit Medical Systems is voluntarily recalling 178 Fluid Management Sets due to a compromised sterile barrier.
Merit Medical Systems is recalling 53 Procedure Kits due to a compromised sterile barrier. The kits were distributed nationwide to specific states and Japan.
Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.
Merit Medical Systems is recalling 40 Manifold Kits (Catalog No. K09-11867AP) because the sterile barrier is compromised, posing a risk of infection.
Merit Medical Systems is voluntarily recalling specific Procedure Kits due to a compromised sterile barrier, which may affect the sterility of the contents.