Four Seasons Glowndark Condoms

Medical device recall

Recall due to failure to comply with the requirements of TGO61 Contraceptive Rubber condoms.

Published

4 June 2003

Level:	Consumer
Class:	II
Reference:	R2003/552
Date agreed:	04 June 2003
Product:	Four Seasons Glowndark Condoms
ARTG number:	AUST L42221
Batch number:	2015, 2016
Expiry	Dec 2006
Sponsor:	Australian Therapeutic Supplies Pty Ltd
Contact:	02 9745 6144 Graham Porter
Reason:	Failure to comply with the requirements of TGO61 Contraceptive Rubber condoms relating to freedom from holes (Batch 2016) and inflation test (2015 and 2016).

Recall letters will be dispatched on 4 June 2003.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I and II recalls are considered to be safety related recalls.

Product types