| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01291-1 |
| Product Name/Description |
Devon Light Glove (Used as a cover with a compatible surgical light handle)
3611 Flexbl Lite Glove 1ea/pkg
Product Code: 31140208
3613 Lite GLV-Flexible 3ea/pkg
Product Code: 31140216
3612 Lite GLV-Flexible 2ea/pkg
Product Code: 31140257
ARTG Number: 186761 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
Customers have reported that on rare occasion (complaint rate less than 2/100,000 or 0.0017%), the Devon Light Glove may split upon application to the Devon Light Handle Adapter. A subset of these splits reportedly resulted from a difficult application of the glove to the handle adapter. A split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. There have been no reports of serious injury associated with these rarely occurring splits. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is adding the statement "After application, inspect the Light Glove for barrier integrity" to the Devon Light Glove Instructions for Use (IFU) and notifying this information to the users through the customer letter.
This action has been closed out on the 06/12/2018. |
| Contact Information |
02 9429 3114 - Covidien Project Manager |