FDA (Devices) recall action 83633
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
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 49,130 AHD Luer Lock Caps because an incomplete seal may cause loss of sterility.
Argon Medical Devices is recalling specific stopcock products because incomplete pouch seals may cause a loss of sterility.
Argon Medical Devices is recalling specific lots of sterile double female and male luer lock adapters because incomplete pouch seals may compromise sterility.
Argon Medical Devices is recalling 49,130 units of TRI-JECT 3 Way IV Administration Organizers because an incomplete seal may cause loss of sterility.
Argon Medical Devices is recalling Septishield II products because an incomplete seal may cause a loss of sterility.
Argon Medical Devices is recalling Hemostasis Valves because incomplete pouch seals may cause a loss of sterility.
Argon Medical Devices is recalling specific lots of Luer Lock Plugs because an incomplete seal may cause a loss of sterility.
Argon Medical Devices is recalling Vascuclamp radiopaque vascular clamps because an incomplete pouch seal may cause a loss of sterility.
Argon Medical Devices is recalling Double Male LL Adapters because an incomplete pouch seal may cause a loss of sterility.