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 & II recalls are considered to be safety related recalls.
