| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00830-1 |
| Product Name/Description |
Hybrid Guidewire (HYBRID12D300)
All lot numbers
UDI-DI: HYBRID12D300 (03700481334447)
ARTG 175484
(Getz Healthcare Pty Ltd - Hybrid Guidewire - Catheter guide wire) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/09/2023 |
| Responsible Entity |
|
| Reason/Issue |
An error on the HYBRID12D300 guidewire drawing on both the pouch and box labels has been identified. The length of the radio-opaque distal tip drawing indicates a 3cm long marker instead of 8cm. The written dimensions contain the correct measurements.
No reports of patient injury have been received to date. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Customers are to be aware of the issue and place the customer letter (supplied to customers by the sponsor) with the affected product.
Stock manufactured after June 2023 will no longer have this issue. |
| Contact Information |
qara.au@getzhealthcare.com - Getz Healthcare |