The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2614-2024·Announced 2024-09-04

Pediatric Tracheostomy Tubes Recalled Due to Defective Securement Flange

Smiths Medical recalls pediatric tracheostomy tubes from specific lots due to a manufacturing defect that may cause the securement flange to tear. No injuries have been reported.

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: "Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect."

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of pediatric tracheostomy tubes in sizes 2.5mm through 5.5mm due to a manufacturing defect. The products were distributed worldwide.

The securement flange of the affected tubes may tear as a result of the manufacturing defect. The recall applies to specific lot numbers identified by product code.

Pediatric tracheostomy tubes are critical medical devices used for airway management in children. These life-sustaining devices require reliable securement components to function safely.

Healthcare providers and institutions should immediately check their inventory against the provided lot numbers. Affected devices should be removed from use and replaced with non-recalled units. Patients and caregivers should contact their healthcare provider for guidance.

The recalled product

Product
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND…
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Tracheostomy / Airway Management
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)

  • a) UDI/DI 10351688518668
  • Product Code/List Number/Item Code 67PFSS25
  • Lot Numbers: 3897874
  • 3911416
  • 3923743
  • 4005596
  • 4016053
  • 4016057
  • 4080314
  • 4087038
  • 4217435
  • 4327880
  • 4334932
  • 4374412
  • 4381000
  • b) UDI/DI 10351688518675
  • Product Code/List Number/Item Code 67PFSS30
  • Lot Numbers: 3853409
  • 3853410
  • 3868326

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 28 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 28 products in this recall →

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