Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue
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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies the agency classification as Class I, which per the rubric is typically a score of 1 or 2 as it is unlikely to cause adverse health consequences. The described hazard is a mechanical difficulty in locking the holder or passing a catheter, with no reported injuries or illnesses.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the H4002PS Neonatal/Paediatric Intubation Kit 3.0mm Murphy, LDS 15mm Conn 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 affected lot numbers are 2474641, 2470638, 2453454, 2448650, 2438611, 2433436, 2428205, 2412133, 2400804, 2347041, 2343292, 2326893, 2298737, 2271338, 2260550, 2211923, 2188448, 2175049, 2135974, 2099500, 2068120, 2042404, 11872, and 11861. Healthcare facilities and consumers should check their inventory for these specific lot numbers and contact Smiths Medical ASD, Inc. for instructions on how to return or replace the affected devices.
The recalled product
- Product
- H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Intubation Kit
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: 2474641
- 2470638
- 2453454
- 2448650
- 2438611
- 2433436
- 2428205
- 2412133
- 2400804
- 2347041
- 2343292
- 2326893
- 2298737
- 2271338
- 2260550
- 2211923
- 2188448
- 2175049
- 2135974
- 2099500
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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