FDA (Devices) recall action 66895
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
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.
Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.
Asante Solutions is recalling 352 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.
Asante Solutions is recalling 246 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery to patients.
Asante Solutions is recalling 834 Comfort Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.
Asante Solutions is recalling Conset Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and delivering less insulin than intended.
Asante Solutions is recalling 1,085 Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.
Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.
Asante Solutions is recalling 635 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.