The Recall Desk
HighFDA (Devices)·Z-2537-2014·Announced 2014-09-03

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 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 where a mechanical defect (tube compression) creates a risk of harm by interfering with critical functions (locking the holder, passing a suction catheter), but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Smiths Medical ASD, Inc. is recalling the H4001S Neonatal/Paediatric Intubation Kit (2.5mm Murphy, 15mm Conn, Holder). The recall involves 135,518 units, with 110,246 distributed nationwide and the remainder distributed internationally to countries including Canada, Cyprus, the United Kingdom, Ireland, Italy, Jersey, Kuwait, Malta, Poland, Russia, Saudi Arabia, and South Africa.

The recall is due to a defect in the ET Tube Holder. The tube fastener on the 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 specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with the use of these devices.

The recalled product

Product
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Intubation Kit
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: 2470637
  • 2470636
  • 2457747
  • 2448649
  • 2443371
  • 2438610
  • 2438609
  • 2428204
  • 2428203
  • 2423483
  • 2412132
  • 2405733
  • 2405732
  • 2394049
  • 2394048
  • 2394047
  • 2389237
  • 2389236
  • 2385647
  • 2380340

Distribution

Distributed in 41 states:

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.

See all 6 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD, Inc.

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Same hazard · mechanical defect

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