FDA (Devices) recall action 82692
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.
Affected products may have been manufactured with the catheter distal end hole too small
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.
Cook Inc. is recalling two Pericardiocentesis Catheter Trays because the catheter distal end hole may be too small.
Cook Inc. is recalling 83 Pericardiocentesis Catheter Sets because the catheter distal end hole may be too small.
Cook Inc. is recalling 5 units of Thoracentesis Sets (Lot NS7662071) because the catheter distal end hole may be too small.
Cook Inc. is recalling two Pericardiocentesis Catheter Trays because the catheter distal end hole may be too small. The affected units were distributed domestically and internationally.