Medical Device Recall: Incorrect Expiration Dates

Detected March 17th, 2026

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.

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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

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

Source document (simplified)

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