| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01128-1 |
| Product Name/Description |
Sage Comfort impregnated cloth topical skin products
(impregnated with barrier creams and/or antiseptic agents & are used to protect &/or clean areas of skin)
Catalogue Numbers: 7453, 7526, 7905, 7413, 7988, 9601, 9602
Various batch numbers affected (see attached)
ARTG Number: 227609 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
The recall was initiated due to product contamination of a few lots of Comfort Shield Barrier Cream Cloths with the bacteria, Burkholderia cepacia, that were manufactured on two production lines. Although the contamination has not been identified in any other products, all products manufactured on the same production lines in the relevant period have also been recalled.
Topical administration of a product with presence of microbial contamination may cause serious infections in immunocompromised persons and in hospitalised patients, as well as certain other patient groups. |
| Recall Action |
Recall |
| Recall Action Instructions |
Teleflex Medical is advising users to inspect stock and quarantine any remaining units of the affected product. Stock can be returned to Teleflex or place of purchase for a credit, refund or replacement. For more details, please see https://www.tga.gov.au/alert/comfort-impregnated-cloth-topical-skin-products . This action has been closed-out on 28/06/2017. |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |