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.
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: This is an FDA Class I recall of a critical medical device with a manufacturing defect affecting securement function. However, no illnesses or injuries have been reported, and the risk is theoretical. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3 (High).
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 STRA
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- manufacturing-defect
- device-failure
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.
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