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Medical Device Recall: Incorrect Expiration Dates

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Summary

Health Canada has issued a recall for several medical devices, including the Approach® CTO Micro Wire Guide and various catheter sets, due to incorrect expiration dates on the labelling. The manufacturer, Cook Incorporated, is providing information to healthcare professionals. This recall impacts multiple lot and model numbers.

Published by Health Canada on recalls-rappels.canada.ca . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

Health Canada has initiated a recall for multiple medical devices manufactured by Cook Incorporated, including the Approach® CTO Micro Wire Guide, Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set, Wayne Pneumothorax Set, and Cook Spectrum® Central Venous Catheter Sets. The reason for the recall is incorrect expiration dates on the product labelling and packaging. The recall affects numerous lot numbers and model numbers across these product lines.

Healthcare providers who have received these affected products are advised to contact the manufacturer, Cook Incorporated, for additional information. While no specific compliance deadline or penalty is mentioned, healthcare facilities must ensure they are not using or distributing devices with incorrect expiration dates to maintain patient safety and regulatory compliance. Failure to address such labelling errors can lead to patient harm and potential regulatory scrutiny.

What to do next

  1. Contact manufacturer Cook Incorporated for additional information regarding affected lots.
  2. Review inventory for affected medical devices and segregate any with incorrect expiration dates.
  3. Ensure no affected devices with incorrect expiration dates are used on patients.

Archived snapshot

Mar 17, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Health product recall

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

Brand(s)

Cook, Incorporated

Last updated

2026-03-17

Summary

Product Approach® CTO Micro Wire Guide, Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set, Wayne Pneumothorax Set, Cook Spectrum® Central Venous Catheter Sets Issue Medical devices - Labelling and packaging What to do Contact the manufacturer if you require additional information.

Audience Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set 15151627 C-PTIS-100-UNL-HC-G-EU
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set 16189597 C-PTIS-100-HC-G-EU
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set 16175956 C-PTIS-100-HC-G-EU
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set 16175949 C-PTIS-100-UNS-HC-G-EU
Cook Five Lumen Central Venous Catheter Set 15478180 C-UQLM-1001J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 16532975 C-UTLM-701J-ABRM-HC-RD-CAH
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial NS15660282 C-UTLM-501J-ABRM-HC-CAH
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15687199 C-UTLM-701J-RSC-ABRM-HC-RD-CAH
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial NS15597521 C-UTLM-501J-PED-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial NS15643882 C-UTLM-501J-PED-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial NS15489151 C-UTLM-501J-PED-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial NS15559871 C-UTLM-501J-PED-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15553839 C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15565537 C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15550737 C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15520384 C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15655329 C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15496521 C-UTLM-501J-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15628883 C-UTLM-501J-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15683408 C-UTLM-701J-RSC-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15660266 C-UTLM-701J-RSC-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial 15655331 C-UTLM-701J-RSC-ABRM-HC-RD
Approach® CTO Micro Wire Guide 15220204 CMW-14-300-18G
Approach® CTO Micro Wire Guide 15898546X CMW-14-190-18G
Approach® CTO Micro Wire Guide 15660224 CMW-14-190-18G
Wayne Pneumothorax Set 15834151 C-UTPT-1400-WAYNE-112497-IMH
Double Lumen Central Venous Catheter Set NS15282763 C-UDLM-401J-LSC-ABRM-HC
Double Lumen Central Venous Catheter Set NS16454756 C-UDLM-801J-ABRM-HC
Double Lumen Central Venous Catheter Set NS16454754 C-UDLM-801J-ABRM-HC
Double Lumen Central Venous Catheter Set 15484947 C-UDLM-401J-ABRM-HC
Double Lumen Central Venous Catheter Set 15520378 C-UDLM-401J-ABRM-HC
Double Lumen Central Venous Catheter Set 15569919 C-UDLM-401J-ABRM-HC
Double Lumen Central Venous Catheter Set 15520367 C-UDLM-401J-PED-ABRM-HC
Double Lumen Central Venous Catheter Set 15557442 C-UDLM-401J-PED-ABRM-HC
Double Lumen Central Venous Catheter Set 15594051 C-UDLM-401J-PED-ABRM-HC
Double Lumen Central Venous Catheter Set NS15582078 C-UDLM-501J-PED-ABRM-HC

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.

Additional information

Details

Original published date:

2026-03-17

Alert / recall type Health product recall Category Health products - Medical devices - Anaesthesiology Health products - Medical devices - Cardiovascular Companies Cook, Incorporated

750 Daniels Way, Bloomington, Indiana, United States, 47404

Published by Health Canada Audience Healthcare Recall class Type II Recall date

2026-03-05

Identification number RA-81737

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Last updated

Classification

Agency
Health Canada
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers
Geographic scope
Canada Canada

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Product Safety Labeling

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