Smiths Medical Tracheostomy Tubes Recalled Due to Pilot Balloon Disconnection Risk
Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.
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: FDA Class I medical device recall with potential for serious harm to a critical airway device. Rule 2 specifies minimum score of 4 for Class I classifications. No deaths or reported injuries prevent a score of 5.
Plain-English summary
Smiths Medical ASD Inc. is recalling multiple lots of its BLUSelect tracheostomy tubes in cuffed configurations, sizes 6.0 through 10.0, sold individually or in 10-packs. Approximately 799,732 units have been distributed worldwide.
The recall is due to a manufacturing defect that could cause the pilot balloon to disconnect from the tracheostomy tube's inflation line. A disconnection could affect the tube's ability to function properly.
Healthcare facilities should discontinue use of affected lots and switch to alternative products. Patients should consult their healthcare provider if they have used or are currently using any recalled tubes.
The FDA classified this as a Class I medical device recall. No injuries or illnesses have been reported.
The recalled product
- Product
- smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075C
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Airway Device
- Hazard
- 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)
- 101/800/060CZ
- Lot Number 3895097
- Lot Number 3925835
- Lot Number 4025600
- Lot Number 4106716
- Lot Number 4230149
- Lot Number 4252500
- Lot Number 4382002
- 101/800/070CZ
- Lot Number 3895101
- Lot Number 3925960
- Lot Number 3933088
- Lot Number 4010050
- Lot Number 4022790
- Lot Number 4034826
- Lot Number 4037975
- Lot Number 4133612
- Lot Number 4152440
- Lot Number 4156971
- Lot Number 4217804
Distribution
Distribution scope not specified by the agency.
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