CanadaThe LEO+ Intracranial Self Expandable Stent and Delivery System (Balt Extrusion Sas), models LEO.3.5X25, LEO.4.5X30 and LEO.4.5X20 with lot/serial numbers 00644632, 00645585, 00633163, 00650473, 00645903 and 00648969 is affected. Balt Extrusion is voluntarily recalling specific ANRYV connector lots after routine quality control identified non-conforming bacterial endotoxin test results; this affects standalone ANRYV connectors and ANRYV connectors incorporated into selected Balt product kits, with no reported patient harm to date. Contact the manufacturer for additional information.
What's being recalled
Companies: Balt Extrusion Sas, 10, Rue Croix-Vigneron, Montmorency, France, 95160.
How to identify it
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00644632; Model or catalogue number: LEO.3.5X25
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645585; Model or catalogue number: LEO.3.5X25
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00633163; Model or catalogue number: LEO.3.5X25
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00650473; Model or catalogue number: LEO.3.5X25
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645903; Model or catalogue number: LEO.3.5X25
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00648969; Model or catalogue number: LEO.3.5X25
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00644632; Model or catalogue number: LEO.4.5X30
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645585; Model or catalogue number: LEO.4.5X30
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00633163; Model or catalogue number: LEO.4.5X30
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00650473; Model or catalogue number: LEO.4.5X30
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645903; Model or catalogue number: LEO.4.5X30
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00648969; Model or catalogue number: LEO.4.5X30
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00644632; Model or catalogue number: LEO.4.5X20
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645585; Model or catalogue number: LEO.4.5X20
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00633163; Model or catalogue number: LEO.4.5X20
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00650473; Model or catalogue number: LEO.4.5X20
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645903; Model or catalogue number: LEO.4.5X20
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00648969; Model or catalogue number: LEO.4.5X20
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00644632; Model or catalogue number: LEO.5.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645585; Model or catalogue number: LEO.5.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00633163; Model or catalogue number: LEO.5.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00650473; Model or catalogue number: LEO.5.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645903; Model or catalogue number: LEO.5.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00648969; Model or catalogue number: LEO.5.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00644632; Model or catalogue number: LEO.3.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645585; Model or catalogue number: LEO.3.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00633163; Model or catalogue number: LEO.3.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00650473; Model or catalogue number: LEO.3.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00645903; Model or catalogue number: LEO.3.5X35
Affected products: LEO+ Intracranial Self Expandable Stent And Delivery System; Lot or serial number: 00648969; Model or catalogue number: LEO.3.5X35
The hazard
As a precautionary measure, Balt Extrusion is voluntarily recalling specific ANRYV connector lots after routine quality control identified non-conforming bacterial endotoxin test results. The recall affects both standalone ANRYV connectors and ANRYV connectors incorporated into selected Balt product kits, despite no reported patient harm to date.
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)