FDA (Devices) recall action 65320
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.
Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.
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.
ConMed Linvatec is recalling APEX Arthroscopy Tubing Sets because a scratch on the pressure fitting may cause the irrigation pump to increase fluid flow to the surgical site.
ConMed Linvatec is recalling APEX Arthroscopy Tubing Sets because a scratch on the pressure fitting may cause the irrigation pump to increase fluid flow to the surgical site.