FDA (Devices) recall action 97165
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.
Potential for external cassette leaks
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.
LVP Blood Products Administration Sets are being recalled because of the potential for external cassette leaks. 14,280 units are affected.
LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.
LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, are being recalled because of the potential for external cassette leaks. 19,225 units are affected.
LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.