Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders
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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the H4052 Endo Tube Holder, Pedi 3.0mm, which is part of the Pediatric Endotracheal Intubation Kit. The recall involves 135,518 units, with 110,246 distributed nationwide and the remainder distributed internationally to Canada, Cyprus, Great Britain, Ireland, Italy, Jersey, Kuwait, Malta, Poland, Russia, Saudi Arabia, and South Africa.
The recall is due to a defect in the tube fastener on the ET Tube Holder. The fastener may compress the tracheal tube when used. This compression may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
The source text does not specify a consumer action or report any illnesses or injuries. The recall is classified as Class I by the FDA.
The recalled product
- Product
- H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 2602399
- 2588625
- 2580799
- 2576366
- 2523679
- 2513119
- 2492246
- 2481855
- 2474647
- 2465829
- 2457754
- 2443379
- 2438616
- 2433451
- 2428215
- 2412146
- 2394061
- 2380352
- 2376566
- 2365454
Distribution
Part of a larger recall action
This product is one of 6 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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