Smiths Medical BLUperc tracheostomy tubes recalled for pilot balloon disconnection
Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is FDA Class I, which per the severity rubric requires a minimum score of 4. The manufacturing defect involves potential disconnection of the pilot balloon from the inflation line in airway management equipment, posing significant risk of harm even without reported incidents.
Plain-English summary
Smiths Medical ASD Inc. is recalling BLUperc Percutaneous Dilation Procedural Trays with BLUselect tracheostomy tubes, along with variant products including BLUgriggs and BLUperc versions. The recall encompasses 41,691 units that were distributed worldwide.
A manufacturing defect has been identified that could cause the pilot balloon to disconnect from the tracheostomy inflation line. This defect affects specific lots of these medical devices.
The FDA has classified this as a Class I recall due to the potential for disconnection of critical components in airway management equipment.
The recalled product
- Product
- smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percuta
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- device-disconnection
- manufacturing-defect
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)
- 101/561/070
- Lot Number 3887555
- Lot Number 3928959
- Lot Number 4005346
- Lot Number 4217858
- Lot Number 4234862
- Lot Number 4266405
- Lot Number 4348810
- 101/561/080
- Lot Number 3887536
- Lot Number 3906566
- Lot Number 3906567
- Lot Number 3906568
- Lot Number 4217859
- Lot Number 4232677
- Lot Number 4238252
- Lot Number 4249230
- Lot Number 4281149
- Lot Number 4281150
- Lot Number 4283700
Distribution
Distribution scope not specified by the agency.
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