Recall MonitorHealth Products
Bard Dynamic Deca Steerable Diagnostic EP Catheter and Daig Livewire Steerable Diagnostic EP Catheter
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Bard Dynamic Deca Steerable Diagnostic EP Catheter and Daig Livewire Steerable Diagnostic EP Catheter
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Bard Dynamic Deca Steerable Diagnostic EP Catheter | More than 10 numbers, contact manufacturer. | 201101 |
| Daig Livewire Steerable Diagnostic EP Catheter | More than 10 numbers, contact manufacturer. | 401904 |
| Daig Livewire Steerable Diagnostic EP Catheter | More than 10 numbers, contact manufacturer. | 401575 |
Issue
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.