Four Seasons Glowndark Condoms
Medical device recall
| Level: | Consumer | Class: | II |
|---|---|---|---|
| Reference: | R2003/552 | Date: | 4 June 2003 |
| Product: | Four Seasons Glowndark Condoms | ||
| ARTG number: | AUST L42221 | ||
| Batch number: | 2015, 2016 | ||
| Expiry | Dec 2006 | ||
| Sponsor: | Australian Therapeutic Supplies Pty Ltd | ||
| Phone: | 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 & II recalls are considered to be safety related recalls.