| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00675-1 |
| Product Name/Description |
StraightShot Microdebrider Blades
Blade Skimmer 3pk 3.5mm 22.5cm
Model Number: 1883523
Lot Numbers: 214388556, 214861292, HG20DTQ and HG21X3J
Blade Tricut 5pk 3.5mm
Model Number: 1883504
Lot Numbers: 0214435413, 0214630819, 0214631786, HG1YVYF, HG1Y58E, HG21X15, HG21CX2, HG1ZTFT and HG2DMDR
Blade 3pk Skimmer Ang 18cm
Model Number: 1883525
Lot Numbers: HG20VDV and HG1YSR6
ARTG Number: 117118 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified that the irrigation pin used to manufacture (moulding) the hub outer tube was incorrectly placed in the mould. The use of a shorter pin resulted in blockage of the irrigation lumen of specific StraightShot Microdebrider Blades.
To date, there have been no reported injuries as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising customers to cease use of affected product. Customers are requested to return unused units by following the instructions outlined in the Customer Letter.
Medtronic is advising clinicians who may have used impacted units to monitor their patient's condition to determine if there are any signs of infection. If infection is present, the patient should seek medical attention immediately for treatment.
This action has been closed out on 22/07/2019 |
| Contact Information |
02 9857 9000 - Medtronic Australasia |