| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00488-1 |
| Product Name/Description |
Medtronic Clip Gun Magazine, Raney Clip Gun 5pk
Model Number: CM8902
Batch Numbers: 54984 and 57188
ARTG Number: 98837
(Medtronic Australasia - Clip, scalp, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified certain Clip Gun Magazines have failed to meet the requirement of post-sterile seal integrity. Testing performed by Medtronic showed that the packaging sterile barrier of the PMC manufactured Magazine CM8902, does not comply with the applicable packaging standard for terminally sterilised medical devices.
Whilst the Instructions for Use (IFU) state “Do not use if package has been previously opened or damaged”, it is possible that the seal breach may go undetected by the users’ naked eye.
To date, Medtronic has not received any complaints related to a sterile breach or infection that could potentially be related to a sterile breach. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising customers to identify affected product and return any unused units to Medtronic. Instructions for return can be found in the Customer Confirmation Form provided with the Customer Letter.
Clinicians and their Patients who may have received the listed devices should monitor the patient’s condition to determine if there are any signs of infection. If this is the case, the patient should seek medical attention immediately to treat the infection.
This action has been closed out on 15/02/2019 |
| Contact Information |
02 9857 9000 - Medtronic Australasia |