FDA (Devices) recall action 72534
The FDA (Devices) publishes a recall like this one as 13 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 13 pages.
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
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.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.
LeMaitre Vascular is recalling 4,315 units of NovaSil Silicone Embolectomy Catheters due to a manufacturing issue that may compromise sterility.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.
LeMaitre Vascular is recalling NovaSil Embolectomy Catheters due to a manufacturing issue that could compromise packaging sterility.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters worldwide due to a manufacturing defect that may compromise sterility.
LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that could compromise sterility.
LeMaitre Vascular is recalling 4,315 embolectomy catheters worldwide due to a manufacturing defect that may compromise packaging sterility.
LeMaitre Vascular is recalling specific embolectomy catheters because a manufacturing defect could compromise sterility.
LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.
LeMaitre Vascular is recalling Single Lumen Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.