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