Comfort impregnated cloth topical skin products
Recall - potential for bacterial contamination
Consumers and health professionals are advised that Teleflex Medical Australia, in consultation with the TGA, is recalling a range of its Comfort impregnated cloth topical skin products due to the potential for bacterial contamination.
These cloths are impregnated with barrier creams and/or antiseptic agents and are used to protect and/or clean areas of skin.
Teleflex Medical Australia has advised that the manufacturer found contamination by bacteria, Burkholderia cepacia, in several lots of its Comfort Shield Barrier Cream Cloths. 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.
Applying a product contaminated with B. cepacia to the skin may cause serious infections in patients with weakened immune systems, including those in hospitals, and some other patient groups.
Products affected by this recall are:
- Comfort Shield Barrier Cream Cloths
- Comfort Shield Perineal Washcloths
- Comfort Personal Cleansing Antiseptic Body Cleansing Washcloths
- Comfort Personal Cleansing Essential Bath Cleansing Washcloths
- Comfort Personal Cleansing Impreva Bath Cleansing Washcloths.
|Product name||Batch number||Expiry date|
|Comfort Shield Perineal Washcloth (3 pack)||45601||31/8/2016|
|Comfort Shield Barrier Cream Cloths (24 pack)||50694||2/2/2017|
|Comfort Shield Barrier Cream Cloths (8 pack)||45602||31/8/2016|
|Comfort Personal Cleansing Essential Bath Cleansing Washcloths (8 pack)||46032||27/9/2016|
|Comfort Personal Cleansing Impreva Bath Cleansing Washcloths (8 pack)||48023||N/A|
|Comfort Personal Cleansing Antiseptic Body Cleansing Washcloths (2 pack)||45465||20/8/2016|
|Comfort Personal Cleansing Antiseptic Body Cleansing Washcloths (6 pack)||45445||19/8/2016|
Information for consumers
If you, or somebody you provide care for, uses any of the Comfort impregnated cloth topical skin products listed above, please be alert to this issue.
Check the packaging and if the product is from an affected batch do not use it. Return it to the place of purchase for refund or replacement.
If you have any concerns or queries, talk to your health professional or call Teleflex Medical Australia Customer Service on 1300 360 226.
Information for health professionals
If you are treating a patient who uses one of the products listed above, be aware of this issue. Advise patients to check the packaging of any products they have and not to use them if they are from affected batches.
Teleflex Medical Australia has written to health facilities providing further details about this issue and the recall process.
If you require further information call Teleflex Medical Australia Customer Service on 1300 360 226.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.