| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00064-1 |
| Product Name/Description |
Covidien Devon Light Glove (included in multiple Procedure Packs)
Multiple Product Codes
ARTG Number for the Light Glove itself: 186761
ARTG Numbers for the affected Procedure Packs containing the Light Glove: 140059, 136870, 137395, 140054 and 140058 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/01/2017 |
| 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 for Product Correction |
| Recall Action Instructions |
Medline is advising users to remove and discard the Covidien Light Glove from the procedure pack at the time of surgery preparation.
This action has been closed out on the 13/12/2018. |
| Contact Information |
1800 110 511 – Medline Customer Service Team |