FDA (Devices) recall action 90622
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.
Outer carton packaging of microcatheters were exposed to wet substance during transport.
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.
Micro Therapeutics is recalling Echelon-14 microcatheters whose outer carton packaging was exposed to a wet substance during transport, posing a risk to device sterility.
Micro Therapeutics is recalling Echelon-14 Micro Catheters because outer packaging was exposed to moisture during transport. The moisture exposure could compromise the sterility or function of the device.