FDA (Devices) recall action 86433
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.
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
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.
Vascular Solutions, Inc. is recalling 89,121 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.
Vascular Solutions, Inc. is recalling 2,990 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.
Vascular Solutions, Inc. is recalling 1,745 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.
Vascular Solutions, Inc. is recalling 1,680 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.