FDA (Devices) recall action 71533
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
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.
Argon Medical Devices is recalling specific T-Lok bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.
Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.