Health Products

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

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology, Health products - Medical devices - Cardiovascular
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set15151627C-PTIS-100-UNL-HC-G-EU
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set16189597C-PTIS-100-HC-G-EU
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set16175956C-PTIS-100-HC-G-EU
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set16175949C-PTIS-100-UNS-HC-G-EU
Cook Five Lumen Central Venous Catheter Set15478180C-UQLM-1001J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial16532975C-UTLM-701J-ABRM-HC-RD-CAH
Triple Lumen Central Venous Catheter Set W/Spectrum Glide AntimicrobialNS15660282C-UTLM-501J-ABRM-HC-CAH
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15687199C-UTLM-701J-RSC-ABRM-HC-RD-CAH
Triple Lumen Central Venous Catheter Set W/Spectrum Glide AntimicrobialNS15597521C-UTLM-501J-PED-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide AntimicrobialNS15643882C-UTLM-501J-PED-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide AntimicrobialNS15489151C-UTLM-501J-PED-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide AntimicrobialNS15559871C-UTLM-501J-PED-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15553839C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15565537C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15550737C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15520384C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15655329C-UTLM-701J-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15496521C-UTLM-501J-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15628883C-UTLM-501J-ABRM-HC
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15683408C-UTLM-701J-RSC-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15660266C-UTLM-701J-RSC-ABRM-HC-RD
Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial15655331C-UTLM-701J-RSC-ABRM-HC-RD
Approach® CTO Micro Wire Guide15220204CMW-14-300-18G
Approach® CTO Micro Wire Guide15898546XCMW-14-190-18G
Approach® CTO Micro Wire Guide15660224CMW-14-190-18G
Wayne Pneumothorax Set15834151C-UTPT-1400-WAYNE-112497-IMH
Double Lumen Central Venous Catheter SetNS15282763C-UDLM-401J-LSC-ABRM-HC
Double Lumen Central Venous Catheter SetNS16454756C-UDLM-801J-ABRM-HC
Double Lumen Central Venous Catheter SetNS16454754C-UDLM-801J-ABRM-HC
Double Lumen Central Venous Catheter Set15484947C-UDLM-401J-ABRM-HC
Double Lumen Central Venous Catheter Set15520378C-UDLM-401J-ABRM-HC
Double Lumen Central Venous Catheter Set15569919C-UDLM-401J-ABRM-HC
Double Lumen Central Venous Catheter Set15520367C-UDLM-401J-PED-ABRM-HC
Double Lumen Central Venous Catheter Set15557442C-UDLM-401J-PED-ABRM-HC
Double Lumen Central Venous Catheter Set15594051C-UDLM-401J-PED-ABRM-HC
Double Lumen Central Venous Catheter SetNS15582078C-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.

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