FDA (Devices) recall action 99333
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.
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
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 its L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm (REF 384620) because the hub may leak or crack, potentially causing therapy interruption, blood loss, or bloodstream infection.
Argon Medical Devices is recalling certain L-Cath PICC catheters because the hub may leak or crack, potentially causing blood loss, infection, or therapy interruption.