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Hot & cold packs - Glenageary Pty Ltd

Medical device recall
Published
Level: Consumer
Class: I
Reference: RN-2008-0753
Date agreed: 16 September 2008
Product: smartchoices™ Breast Soother®
ARTG number: 131335
Sponsor: Glenageary Pty Ltd (trading as HumanCare Pty Ltd)
Contact: 1300 554 509 Customer Service
Reason: This product contains the toxic substance ethylene glycol (rather than the non-toxic ingredient propylene glycol).
Recall letters are expected to be dispatched by the sponsor to retailers from Wednesday 17 September 2008. Recall notices advising consumers of this recall will appear in the media as soon as the sponsor of the Breast Soother® is able to obtain advertising space in national newspapers.

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.

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