FDA (Devices) recall action 81837
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.
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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 voluntarily recalling 6,553 units of Tissu-Trans FILTRON 2000 sterile, disposable, one-patient use devices due to a Class II classification.
Shippert Medical Technologies is recalling Tissu-Trans Syringe Fill 360 devices because the sterile pouch integrity cannot be assured without visual examination.
Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 sterile pouches because a cut or hole may compromise sterility.
Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 1000 sterile, disposable, one-patient use devices due to a Class II safety concern.
Shippert Medical Technologies is recalling Tissu-Trans FILTRON 250 sterile filters because the pouch integrity cannot be assured without visual examination.
Shippert Medical Technologies is recalling Tissu-Trans FILTRON 100 sterile pouches because a cut or hole may compromise the product's sterility.
Shippert Medical Technologies is recalling Tissu-Trans FILTRON 500 sterile pouches because a cut or hole in the packaging may compromise the product's sterility.