| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01017-1 |
| Product Name/Description |
Comfort Marker 2.0 Safety Needle used with the Medical Precision Comfort Marker 2.0 Patient Marking System
Lot numbers: 20220919001, 20221121001, 20230321001, 20230209001
Expiry dates: 30/09/2024, 30/11/2024, 30/03/2025, 28/02/2025
ARTG 343473
(Gamma Gurus Pty Ltd - Tattoo needle)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Comfort Marker 2.0 Safety Needle was CE certified by ECM for a shelf life of 1 year.
Testing was successfully conducted to extend the shelf life to 2 years. However, the manufacturer did not officially submit this change to the overseeing Notified Body ECM for review and approval.
Some lots have been released showing the incorrect 2-year expiry.
There is no foreseeable increase in risk or potential hazard that could result from the use of the product.
All testing to achieve the shelf-life extension were performed and passed on 2 year real-aged samples. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Users must identify the batch number of the Safety Needles that they have in stock and update expiry on stock to reflect the one-year expiry.
Gamma Gurus Pty Ltd will supply customers with stickers displaying the accurate expiry date for them to affix onto both the boxes and each individual bag.
Customers should contact the sponsor to arrange replacement of expired stock.
This action has been closed out on 11/01/2024 |
| Contact Information |
0432 414 419 - Gamma Gurus Pty Ltd |