The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2538-2014·Announced 2014-09-03

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.

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 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
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: 2474641
  • 2470638
  • 2453454
  • 2448650
  • 2438611
  • 2433436
  • 2428205
  • 2412133
  • 2400804
  • 2347041
  • 2343292
  • 2326893
  • 2298737
  • 2271338
  • 2260550
  • 2211923
  • 2188448
  • 2175049
  • 2135974
  • 2099500

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 · mechanical defect

See all →

Similar recalls