FDA (Devices) recall action 96541
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
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 ReNewal is recalling 224 units of ENT Coblator II PROcise mAx devices because the drip chambers may disconnect from the saline line tubing under tension, creating a potential surgical hazard.
Medline is recalling 20 units of ReNewal Coblator II ENT devices because drip chambers may disconnect from saline tubing under tension, potentially disrupting fluid delivery during procedures.
Medline Industries is recalling 738 units of the ReNewal Coblator II Evac 70 Xtra Plasma Wand due to risk that drip chambers may disconnect from the saline line tubing under tension.
Medline has recalled 315 units of the ReNewal ENT Coblator II PROcise XP Wand nationwide because the drip chamber may disconnect from the saline line tubing under tension.