FDA (Devices) recall action 85623
The FDA (Devices) publishes a recall like this one as 22 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 22 pages.
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The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
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.
LivaNova USA Inc. is voluntarily recalling 220 units of 3/8 inch Y connectors due to a Class II defect.
LivaNova USA Inc. is recalling 240 units of sterile standalone connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 768 units of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 150 units of Vein Irrigation Cannulas with blunt tips because internal tests identified potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 120 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.
LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 20 units of Sterile Standalone Connectors because internal tests identified potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling specific lots of sterile standalone connectors because internal tests found the sterile barrier may be breached.
LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors because internal tests identified a potential breach in the sterile barrier.
LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.
LivaNova USA Inc. is recalling 240 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.
LivaNova USA Inc. is recalling 420 units of sterile standalone connectors because internal tests identified potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 648 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.
LivaNova USA Inc. is recalling 600 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.
LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests identified potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling 744 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.
LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.
LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.