PRA number
2016/15642
Published date
Product description
Products that are impregnated with barrier creams and/or antiseptic agents, which are used to protect and/or clean areas of skin.
Affected products:
Comfort Shield Barrier Cream Cloths (catalogue numbers 7526 and 7905)
Comfort Shield Perineal Washcloths (catalogue number 7453)
Comfort Personal Cleansing Antiseptic Body Cleansing Washcloths (catalogue numbers 9601 and 9602)
Comfort Personal Cleansing Essential Bath Cleansing Washcloths (catalogue number 7413)
Comfort Personal Impreva Bath Cleansing Washcloths (catalogue number7988 )
ARTG Number 227609
Various batches and expiry dates are affected (see attached list)
Affected products:
Comfort Shield Barrier Cream Cloths (catalogue numbers 7526 and 7905)
Comfort Shield Perineal Washcloths (catalogue number 7453)
Comfort Personal Cleansing Antiseptic Body Cleansing Washcloths (catalogue numbers 9601 and 9602)
Comfort Personal Cleansing Essential Bath Cleansing Washcloths (catalogue number 7413)
Comfort Personal Impreva Bath Cleansing Washcloths (catalogue number7988 )
ARTG Number 227609
Various batches and expiry dates are affected (see attached list)
Reasons the product is recalled
Some batches of the products are contaminated with the bacteria Burkholderia cepacia.
The hazards to consumers
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.
What consumers should do
If you or someone you provide care for, uses any of the Comfort impregnated cloth topical skin products listed, please be alert to this issue.
Check the packaging and if the products is from an affected batch, do not use it. Return it to the place of purchase for a refund or a replacement product.
If you have any concerns or queries, talk to your health professional or call Teleflex Medical Australia Customer Service on 1300 360 226.
Supplier
Teleflex Medical Australia Pty Ltd
Traders who sold this product
Hospitals, health services and other distributers nationally
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.