FDA (Devices) recall action 68739
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
The agency’s own wording, quoted from the enforcement report.
Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.
Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.
Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.
Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.
Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.
Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.