| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00308-1 |
| Product Name/Description |
Fischer Cone Biopsy Excisor
Size medium (5/box)
Part Number: AP-900-151
Lot Number: 212074
ARTG Number: 215626
(Life Healthcare - Electrode, electrosurgical, active, foot-controlled, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Finished product in lot number 212074 was identified to have been incorrectly labelled.
The label incorrectly indicates the part number used for large size instead of the medium size excisor.
This discrepancy does not meet the product release specifications. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to isolate these items and place affected units in the supplied plastic bag for collection by LifeHealthcare. Replacement stock will be provided in due course.
A copy of the Reply Form attached to the Customer Letter should be returned by fax or email and also be enclosed with the stock to be returned.
This action has been closed out on 09/07/2019 |
| Contact Information |
02 8114 1553 - Customer Service Support |