FDA (Devices) recall action 77518
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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.
Shippert Medical Technologies is recalling Tissu-Trans SFILL 360 devices because the seal integrity of the sterile packages cannot be assured.
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 250 because the seal integrity of the sterile packages cannot be assured.
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 1000 because the seal integrity of the sterile packages cannot be assured.
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 2000 because the sterile package seal integrity cannot be assured.
Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 devices because the seal integrity of the sterile packages cannot be assured.
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 500 because the seal integrity of the sterile packages cannot be assured.
Shippert Medical Technologies is recalling Tissu-Trans Filtron 100 units because the seal integrity of the sterile packages cannot be assured.