| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00330-1 |
| Product Name/Description |
Covidien EEA Haemorrhoid and Prolapse Stapler Set with DST Series Technology - 3.5mm staple and 4.8mm staple devices
Product Codes: HEM3335 and HEM3348
Lot Numbers: N7K0692MX, N7L0594MX, N7J1145MX, N7M0837MX, N7M0837MX
ARTG Number: 178674
(Medtronic Australasia - Applier, surgical staple, cutting) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified the potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding and/or an anastomotic leak. This issue was identified during in-process quality testing at the manufacturing facility.
To date, there have been no reports of serious injury related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising customers to quarantine and discontinue use of the affected product immediately. Upon receipt of the Response Form provided with the Customer Letter, Medtronic will provide users with a ZRE# to return product and issue credit.
This action has been closed out on 16/04/2019 |
| Contact Information |
02 9857 9000 - Medtronic |