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

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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