| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00867-1 |
| Product Name/Description |
Approach Micro Wire Guide Devices
Hydro ST Microwire Wire Guide - Ref part #: HMW-14-190-ST, lot #: 15849644
CTO Microwire Wire Guide - Ref part #: CMW-14-300-18G, lot #’s: NS15811659, NS15898544, NS15898545
ARTG 224864
(William A Cook Australia Pty Ltd - Peripheral vascular guidewire) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
Cook Medical has identified that devices from the affected lots have labels that state the incorrect expiration dates.
During a review of label prints, lots with labels stating incorrect expiration dates were detected due to a calculation error in Cook’s labelling software, which uses a calculator to determine the correct expiration date. The calculator assigned the maximum potential shelf life to lots in scope rather than the actual shelf life. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should examine inventory immediately to determine if they have affected product.
If so, customers should immediately quarantine any affected products and cease all further distribution and use of the affected products.
Customers can return the affected products to Cook Medical to receive a product credit. |
| Contact Information |
1800 777 222 - Cook Medical Customer Relations |