The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2540-2014·Announced 2014-09-03

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.

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 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.
Category
Medical Device — Intubation Equipment
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: 2597332
  • 2585074
  • 2580798
  • 2576365
  • 2564404
  • 2564403
  • 2563088
  • 2549367
  • 2519413
  • 2500170
  • 2488207
  • 2474646
  • 2465828
  • 2453473
  • 2443378
  • 2438615
  • 2433450
  • 2412145
  • 2380351
  • 2376498

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.

See all →

Same hazard · device malfunction

See all →

Similar recalls