FDA (Devices) recall action 84908
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.
The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
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.
Medline Industries is recalling 122 units of HOI Lumbar Complete Delivery Systems because the sterile packs did not complete a sterilization cycle, compromising sterility.
Medline Industries is recalling 122 units of the Robotic-LF Complete Delivery System because the sterile packs did not complete a sterilization cycle, meaning sterility cannot be guaranteed.