Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Compression
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could impede critical airway management tasks (locking the holder or passing a suction catheter). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class I (which typically maps to Low/Moderate for devices, but the functional risk to airway management elevates it to High under the 'risk-of-harm' criterion without reported injury).
Plain-English summary
Smiths Medical ASD, Inc. is recalling the H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit. The recall involves 135,518 units, with 110,246 distributed nationwide and the remainder distributed internationally to specific countries including Canada, Cyprus, Great Britain, Ireland, Italy, Jersey, Kuwait, Malta, Poland, Russia, Saudi Arabia, and South Africa.
The recall was initiated because the tube fastener on the ET Tube Holder 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 report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and consumers should stop using the affected products and contact Smiths Medical ASD, Inc. for instructions on return or replacement. The affected lot numbers are listed in the structured product information provided by the agency.
The recalled product
- Product
- H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
- Manufacturer
- Smiths Medical ASD, Inc.
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: 2597332
- 2585074
- 2580798
- 2576365
- 2564404
- 2564403
- 2563088
- 2549367
- 2519413
- 2500170
- 2488207
- 2474646
- 2465828
- 2453473
- 2443378
- 2438615
- 2433450
- 2412145
- 2380351
- 2376498
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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