CanadaCook, Incorporated medical devices including Approach CTO Micro Wire Guide, Blue Rhino G2‑Multi Percutaneous Tracheostomy Introducer Set, Wayne Pneumothorax Set, and Cook Spectrum central venous catheter sets are affected; affected items are identified by specific lot and catalogue numbers listed in the notice. They were recalled because some device labels state incorrect expiration dates that are longer than the actual shelf-life. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Cook, Incorporated, 750 Daniels Way, Bloomington, Indiana, United States, 47404.
How to identify it
Affected products: Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set; Lot or serial number: 15151627; Model or catalogue number: C-PTIS-100-UNL-HC-G-EU
Affected products: Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set; Lot or serial number: 16189597; Model or catalogue number: C-PTIS-100-HC-G-EU
Affected products: Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set; Lot or serial number: 16175956; Model or catalogue number: C-PTIS-100-HC-G-EU
Affected products: Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set; Lot or serial number: 16175949; Model or catalogue number: C-PTIS-100-UNS-HC-G-EU
Affected products: Cook Five Lumen Central Venous Catheter Set; Lot or serial number: 15478180; Model or catalogue number: C-UQLM-1001J-ABRM-HC-RD
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 16532975; Model or catalogue number: C-UTLM-701J-ABRM-HC-RD-CAH
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: NS15660282; Model or catalogue number: C-UTLM-501J-ABRM-HC-CAH
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15687199; Model or catalogue number: C-UTLM-701J-RSC-ABRM-HC-RD-CAH
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: NS15597521; Model or catalogue number: C-UTLM-501J-PED-ABRM-HC
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: NS15643882; Model or catalogue number: C-UTLM-501J-PED-ABRM-HC
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: NS15489151; Model or catalogue number: C-UTLM-501J-PED-ABRM-HC
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: NS15559871; Model or catalogue number: C-UTLM-501J-PED-ABRM-HC
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15553839; Model or catalogue number: C-UTLM-701J-ABRM-HC-RD
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15565537; Model or catalogue number: C-UTLM-701J-ABRM-HC-RD
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15550737; Model or catalogue number: C-UTLM-701J-ABRM-HC-RD
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15520384; Model or catalogue number: C-UTLM-701J-ABRM-HC-RD
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15655329; Model or catalogue number: C-UTLM-701J-ABRM-HC-RD
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15496521; Model or catalogue number: C-UTLM-501J-ABRM-HC
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15628883; Model or catalogue number: C-UTLM-501J-ABRM-HC
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15683408; Model or catalogue number: C-UTLM-701J-RSC-ABRM-HC-RD
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15660266; Model or catalogue number: C-UTLM-701J-RSC-ABRM-HC-RD
Affected products: Triple Lumen Central Venous Catheter Set W/Spectrum Glide Antimicrobial; Lot or serial number: 15655331; Model or catalogue number: C-UTLM-701J-RSC-ABRM-HC-RD
Affected products: Approach® CTO Micro Wire Guide; Lot or serial number: 15220204; Model or catalogue number: CMW-14-300-18G
Affected products: Approach® CTO Micro Wire Guide; Lot or serial number: 15898546X; Model or catalogue number: CMW-14-190-18G
Affected products: Approach® CTO Micro Wire Guide; Lot or serial number: 15660224; Model or catalogue number: CMW-14-190-18G
Affected products: Wayne Pneumothorax Set; Lot or serial number: 15834151; Model or catalogue number: C-UTPT-1400-WAYNE-112497-IMH
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: NS15282763; Model or catalogue number: C-UDLM-401J-LSC-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: NS16454756; Model or catalogue number: C-UDLM-801J-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: NS16454754; Model or catalogue number: C-UDLM-801J-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: 15484947; Model or catalogue number: C-UDLM-401J-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: 15520378; Model or catalogue number: C-UDLM-401J-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: 15569919; Model or catalogue number: C-UDLM-401J-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: 15520367; Model or catalogue number: C-UDLM-401J-PED-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: 15557442; Model or catalogue number: C-UDLM-401J-PED-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: 15594051; Model or catalogue number: C-UDLM-401J-PED-ABRM-HC
Affected products: Double Lumen Central Venous Catheter Set; Lot or serial number: NS15582078; Model or catalogue number: C-UDLM-501J-PED-ABRM-HC
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)