| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00476-1 |
| Product Name/Description |
CQ Medical MPCM4022INT Medical Precision Patient Marking Set
Lot number: 20230929001
Expiry date: 30 Sep 2024
ARTG 343473
(Gamma Gurus Pty Ltd - Tattoo needle) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
A problem with the moulding machine used to mould the plastic part of the Safety Needle has been identified, which caused a small piece of plastic to remain on the outer part of the Safety Needle. This has the potential to cause the Safety Needle to be more difficult to attach to the pen of the Comfort Marker 2.0. If the residue plastic part is too big it could be that the Safety Needle cannot be attached to the pen and the Safety Needle needs to be discarded.
If the Safety Needle cannot be inserted into the pen of the Comfort Marker 2.0 this could result in the healthcare professional needing to use another needle or having to carry out manual tattooing for placement. There is no patient risk associated with this problem. |
| Recall Action |
Recall |
| Recall Action Instructions |
No alternative stock is available currently. Alternative stock is expected to be available from CQ Medical on Q3 2024 and will be shipped to customers when available.
1) In case the needle is stiff in the mounting of the pen, but can still be attached, customers can continue to use the needle while following the instructions provided in section 5.3 of the IFU when mounting the needle into the pen.
2) In case the needle is very difficult to attach to the pen and it is not possible to attach with slight pressure, the customer is to remove the needle from use and discard. Customers are to keep track of the number of affected needles and replacement needles will be provided when available. |
| Contact Information |
02 9520 1966 - Gamma Gurus |