CanadaBard Dynamic Deca Steerable Diagnostic EP Catheter (model 201101) and Daig Livewire Steerable Diagnostic EP Catheter (models 401904 and 401575) are affected; lot/serial numbers are more than 10 digits—contact the manufacturer to confirm if yours is included. Stryker Sustainability Solutions received complaints reporting breached sterile barriers on the chevron seal side of the primary Tyvek pouch. Contact the manufacturer for additional information.
What's being recalled
Companies: Stryker Sustainability Solutions, 1810 West Drake Dr., Tempe, Arizona, United States, 85283.
How to identify it
Affected products: Bard Dynamic Deca Steerable Diagnostic EP Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 201101
Affected products: Daig Livewire Steerable Diagnostic EP Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 401904
Affected products: Daig Livewire Steerable Diagnostic EP Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 401575
The hazard
Stryker Sustainability Solutions (SSS) has received complaints reporting EP catheter devices with breached sterile barriers on the chevron seal side of the primary Tyvek pouch.
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)
United States