Public recall detail

Approach® CTO Micro Wire Guide, Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set, Wayne Pneumothorax Set, Cook Spectrum® Central Venous Catheter Sets

2026-03-17

medium
Anaesthesiology - Cardiovascular Labelling and packaging
Quick summary

Quick summary: Approach® CTO Micro Wire Guide, Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set, Wayne Pneumothorax Set, Cook Spectrum® Central Venous Catheter Sets. Reason: Labelling and packaging. Category: Anaesthesiology - Cardiovascular. Date: 2026-03-17.

Recommended action

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

Recall details

Quick summary: Approach® CTO Micro Wire Guide, Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set, Wayne Pneumothorax Set, Cook Spectrum® Central Venous Catheter Sets. Reason: Labelling and packaging. Category: Anaesthesiology - Cardiovascular. Date: 2026-03-17.

Official details

Affected product details

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

BrandCook, Incorporated
ProductApproach® CTO Micro Wire Guide, Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set, Wayne Pneumothorax Set, Cook Spectrum® Central Venous Catheter Sets
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-81737

Affected products

ProductBlue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
Lot15151627
ModelC-PTIS-100-UNL-HC-G-EU
Serial number15151627
DescriptionBlue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
ProductBlue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
Lot16189597
ModelC-PTIS-100-HC-G-EU
Serial number16189597
DescriptionBlue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
ProductBlue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
Lot16175956
ModelC-PTIS-100-HC-G-EU
Serial number16175956
DescriptionBlue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
ProductBlue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
Lot16175949
ModelC-PTIS-100-UNS-HC-G-EU
Serial number16175949
DescriptionBlue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
ProductCook Five Lumen Central Venous Catheter Set
Lot15478180
ModelC-UQLM-1001J-ABRM-HC-RD
Serial number15478180
DescriptionCook Five Lumen Central Venous Catheter Set
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot16532975
ModelC-UTLM-701J-ABRM-HC-RD-CAH
Serial number16532975
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
LotNS15660282
ModelC-UTLM-501J-ABRM-HC-CAH
Serial numberNS15660282
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15687199
ModelC-UTLM-701J-RSC-ABRM-HC-RD-CAH
Serial number15687199
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
LotNS15597521
ModelC-UTLM-501J-PED-ABRM-HC
Serial numberNS15597521
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
LotNS15643882
ModelC-UTLM-501J-PED-ABRM-HC
Serial numberNS15643882
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
LotNS15489151
ModelC-UTLM-501J-PED-ABRM-HC
Serial numberNS15489151
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
LotNS15559871
ModelC-UTLM-501J-PED-ABRM-HC
Serial numberNS15559871
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15553839
ModelC-UTLM-701J-ABRM-HC-RD
Serial number15553839
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15565537
ModelC-UTLM-701J-ABRM-HC-RD
Serial number15565537
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15550737
ModelC-UTLM-701J-ABRM-HC-RD
Serial number15550737
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15520384
ModelC-UTLM-701J-ABRM-HC-RD
Serial number15520384
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15655329
ModelC-UTLM-701J-ABRM-HC-RD
Serial number15655329
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15496521
ModelC-UTLM-501J-ABRM-HC
Serial number15496521
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15628883
ModelC-UTLM-501J-ABRM-HC
Serial number15628883
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15683408
ModelC-UTLM-701J-RSC-ABRM-HC-RD
Serial number15683408
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15660266
ModelC-UTLM-701J-RSC-ABRM-HC-RD
Serial number15660266
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
Lot15655331
ModelC-UTLM-701J-RSC-ABRM-HC-RD
Serial number15655331
DescriptionTriple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial
ProductApproach® CTO Micro Wire Guide
Lot15220204
ModelCMW-14-300-18G
Serial number15220204
DescriptionApproach® CTO Micro Wire Guide
ProductApproach® CTO Micro Wire Guide
Lot15898546X
ModelCMW-14-190-18G
Serial number15898546X
DescriptionApproach® CTO Micro Wire Guide
ProductApproach® CTO Micro Wire Guide
Lot15660224
ModelCMW-14-190-18G
Serial number15660224
DescriptionApproach® CTO Micro Wire Guide
ProductWayne Pneumothorax Set
Lot15834151
ModelC-UTPT-1400-WAYNE-112497-IMH
Serial number15834151
DescriptionWayne Pneumothorax Set
ProductDouble Lumen Central Venous Catheter Set
LotNS15282763
ModelC-UDLM-401J-LSC-ABRM-HC
Serial numberNS15282763
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
LotNS16454756
ModelC-UDLM-801J-ABRM-HC
Serial numberNS16454756
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
LotNS16454754
ModelC-UDLM-801J-ABRM-HC
Serial numberNS16454754
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
Lot15484947
ModelC-UDLM-401J-ABRM-HC
Serial number15484947
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
Lot15520378
ModelC-UDLM-401J-ABRM-HC
Serial number15520378
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
Lot15569919
ModelC-UDLM-401J-ABRM-HC
Serial number15569919
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
Lot15520367
ModelC-UDLM-401J-PED-ABRM-HC
Serial number15520367
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
Lot15557442
ModelC-UDLM-401J-PED-ABRM-HC
Serial number15557442
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
Lot15594051
ModelC-UDLM-401J-PED-ABRM-HC
Serial number15594051
DescriptionDouble Lumen Central Venous Catheter Set
ProductDouble Lumen Central Venous Catheter Set
LotNS15582078
ModelC-UDLM-501J-PED-ABRM-HC
Serial numberNS15582078
DescriptionDouble Lumen Central Venous Catheter Set

Issue

Devices from the affected device lots have labels that state the incorrect expiration dates. Investigation determined that there were errors in the process which sets a product's expiration date based on the earliest expiring component for certain products, rather than a fixed shelf life. These errors resulted in label expiration dates that did not accurately account for all components or materials. As a result, some products were labeled with expiration dates that were longer than the actual shelf-life.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology Health products - Medical devices - Cardiovascular
CompaniesCook, Incorporated 750 Daniels Way, Bloomington, Indiana, United States, 47404
Recall date2026-03-05
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81737
Background{}
CompaniesCook, Incorporated 750 Daniels Way, Bloomington, Indiana, United States, 47404
AudiencesHealthcare
Source updated2026-03-17

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

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