Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue
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.
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 recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric, despite the lack of reported injuries in the source text.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 135,518 units of the 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit. The recall involves specific lot numbers distributed worldwide, including across the United States and internationally to countries such as Canada, the United Kingdom, and Italy.
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 injuries or illnesses associated with this defect.
Healthcare providers and consumers should stop using the affected kits and contact Smiths Medical ASD, Inc. for further instructions or a replacement. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn 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: 2470635
- 2453453
- 2443370
- 2438608
- 2412131
- 2394050
- 2380339
- 2380338
- 2376475
- 2361590
- 2352067
- 2322810
- 2271334
- 2260548
- 2223901
- 2208177
- 2202236
- 2191909
- 2161059
- 2077168
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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