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

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:
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
Identification number
RA-81737

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