| 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). |
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.
Product types