| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00633-1 |
| Product Name/Description |
Endo Peanut 5mm Device
Item Code:173019
Lot Numbers: M5K04X to M7A01X
Expiry date: October 2020 through to January 2022
ARTG Number:178599 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports that the cotton tip of the device may disengage due to insufficient adhesive application during the manufacturing process. The use of products with this issue may increase the potential for the tip to disengage, resulting in possible extension of operating room time or the need for unintended radiation exposure via x-ray for detection of the foreign body. Four injuries have been observed in the field in which the cotton tip disengaged into the patient requiring unanticipated use of X-Ray to locate the missing cotton (and in one case the tip was not retrieved subsequent to X-Ray). |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is requesting users quarantine and discontinue use of the affected item codes and lots. Medtronic will arrange for pick-up of the stock and will provide credit.
This action has been closed out on 21/08/2019 |
| Contact Information |
02 9429 4325 - Medtronic |