Public recall detail

BLUSelect®, BLUgriggs® and BLUperc® Products

2024-06-10

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Recall Safety notice
Quick summary

Quick summary: BLUSelect®, BLUgriggs® and BLUperc® Products. Date: 2024-06-10.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: BLUSelect®, BLUgriggs® and BLUperc® Products. Date: 2024-06-10.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSmiths Medical Asd Inc.
ProductBLUSelect®, BLUgriggs® and BLUperc® Products
IssueMedical devices - Performance
Recall classType I
IdentificationRA-75653

Affected products

ProductBLUgriggs Percutaneous Dilation Tracheostomy Kit
LotMore than 10 numbers, contact manufacturer.
Model101/541/080
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBLUgriggs Percutaneous Dilation Tracheostomy Kit
ProductBLUperc Percutaneous Dilation Tracheostomy Kit
LotMore than 10 numbers, contact manufacturer.
Model101/563/080 101/563/070 101/561/080 101/561/090 101/561/070
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBLUperc Percutaneous Dilation Tracheostomy Kit
ProductBLUSelect Tracheostomy Tubes
LotMore than 10 numbers, contact manufacturer.
Model101/815/075 101/815/090 101/817/080 101/817/060 101/817/090 101/875/060 101/815/070 101/815/100 101/875/070 101/815/080 101/817/070 101/875/090 101/875/080 101/875/085 101/815/060 101/815/085 101/875/075
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBLUSelect Tracheostomy Tubes

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesSmiths Medical Asd, Inc. 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75653
Background{}
CompaniesSmiths Medical Asd, Inc. 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
AudiencesHealthcare
Source updated2024-06-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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