FDA (Devices) recall action 87284
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.
Sterility may be compromised due to an unsealed pouch
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.
Medtronic Vascular is recalling 137 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.
Medtronic Vascular is recalling 6F Launcher Guide Catheters because an unsealed pouch may compromise sterility.
Medtronic Vascular is recalling 10 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.
Medtronic Vascular is recalling 9 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.