The Recall Desk
HighFDA (Devices)·Z-2539-2014·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 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 with a functional defect that may impede critical airway management tasks (locking the holder or passing a suction catheter). Per the rubric, this is a risk-of-harm product where injury has not yet been reported, corresponding to a score of 3.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 135,518 units of the H4002S Neonatal/Paediatric Intubation Kit 3.0mm Murphy, 15mm Conn, Holder. The recall affects 110,246 units 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 lots are identified by specific lot numbers listed in the recall documentation. Consumers and healthcare facilities should stop using the affected kits and contact Smiths Medical ASD, Inc. for instructions on return or replacement.

The recalled product

Product
H4002S Neonatal/Paed.Intubation Kit 3.0mm 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: 2481849
  • 2474643
  • 2470640
  • 2470639
  • 2465819
  • 2462292
  • 2462291
  • 2457748
  • 2453455
  • 2448671
  • 2443372
  • 2438612
  • 2428206
  • 2420088
  • 2412135
  • 2394046
  • 2394045
  • 2394044
  • 2385648
  • 2380341

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 →