| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00395-1 |
| Product Name/Description |
Medline Procedure Packs containing Covidien Devon Light Gloves
Product Code: 571711
Lot Numbers: 508xxxx and below
ARTG number: 136870 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
This recall has been initiated from the advice of Medline’s supplier Medtronic, involving Lot numbers 508xxxx and below. These Light Gloves may contain splits and pin holes. If a clinician touches the handle unaware that the light glove is split and or contains pin holes, microorganisms from the light handle could be transferred to the clinician and thus patient, resulting in risk of surgical site infection. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medline is advising end users to remove the Light Glove from the procedure pack and discard at the point of surgery. This action has been closed-out on 16/02/2016. |
| Contact Information |
1800 110 511 - Medline Customer Service Team |