The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter."

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 →

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