FDA (Devices) recall action 63596
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
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.
Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets because a manufacturing defect could cause a small tube to become dislodged.
Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.
Carl Zeiss Meditec is recalling INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.