BLUSelect®, BLUgriggs® and BLUperc® Products
Brand(s)
Last updated
Summary
Product
BLUSelect®, BLUgriggs® and BLUperc® Products
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products | Lot or serial number | Model or catalog number |
---|---|---|
BLUgriggs Percutaneous Dilation Tracheostomy Kit | More than 10 numbers, contact manufacturer. | 101/541/080 |
BLUperc Percutaneous Dilation Tracheostomy Kit | More than 10 numbers, contact manufacturer. | 101/563/080 101/563/070 101/561/080 101/561/090 101/561/070 |
BLUSelect Tracheostomy Tubes | More than 10 numbers, contact manufacturer. | 101/815/075 101/815/090 101/817/080 101/817/060 101/817/090 101/875/060 101/815/070 101/815/100 101/875/070 101/815/080 101/817/070 101/875/090 101/875/080 101/875/085 101/815/060 101/815/085 101/875/075 |
Issue
Smiths Medical has identified the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect®, BLUgriggs® and BLUperc® products because of a manufacturing defect.
Recall Start Date: June 3, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Smiths Medical Asd, Inc.
6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75653
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