| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01148-1 |
| Product Name/Description |
Fixed Core Wire Guide and Roadrunner Hydrophilic Wire Guide
Lot numbers for Fixed Core Wire Guide: 14821853, 14833106, 14811925, NS14795068
Lot number for Roadrunner Hydrophilic Wire Guide: NS14828650
ARTG: 153527, 153528, 153531 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/08/2022 |
| Responsible Entity |
|
| Reason/Issue |
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
The affected devices may be non-sterile or contaminated with microorganisms. Potential adverse events that may occur if an affected product is used include infection, potentially being life-threatening and/or requiring medical/surgical intervention.
To date, Cook Medical has not received any customer complaints related to the adverse patient effects listed above for the affected lots. However, please be advised that compromised device sterility may go undetected by the user. |
| Recall Action |
Recall |
| Recall Action Instructions |
Cook Medical are advising customers to quarantine and return any unused affected stock for a credit.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 777 222 - Cook Medical Customer Relations |