| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00008-1 |
| Product Name/Description |
Covidien Devon Light Glove
Product Codes: 571711, 31140208, 31140216, 31140257
All Lot Numbers within expiry beginning with 630XXXXXXX and lower
ARTG Number: 186761 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Customers have reported that on rare occasions, the Devon Light Glove may split upon application to the Devon Light Handle Adapter. Some of the reported splits resulted from difficult application of the Light Glove to the Handle Adapter. More recently, clinicians have reported finding splits in the Light Glove following surgery completion, where no difficulty in application of the Light Glove was encountered or finding splits directly out of the package. A split in the Light Glove causes a breach in the sterile field and can increase the potential for infection. There have been two reports in which splits were found at the conclusion of surgery. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising the distributor to quarantine and discontinue use of the affected lots prior to returning them for a credit. The distributor is further requested to forward the recall letter to hospitals with the affected lots.
This action has been closed out on the 11/12/2018. |
| Contact Information |
02 9857 9000 - Medtronic |