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Hot & cold packs - Orthopaedic Appliances Pty Ltd

Medical device recall
Published
Level: Consumer
Class: I
Reference: RN-2008-0750
Date agreed: 15 September 2008
Product: SOFT cold hot pack (label on product) sold as OAPL professional reusable hot and cold pack
ARTG number: 130191
Sponsor: Orthopaedic Appliances Pty Ltd
Contact: 1800 033 207 Customer service
Reason: This product contains the toxic substance ethylene glycol (rather than the non-toxic ingredient propylene glycol).
Recall letters will be dispatched by the sponsor to pharmacies from Tuesday 16 September 2008. Recall notices advising consumers of this recall will appear in the media as soon as the sponsor of this Hot/Cold Pack 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.

Product types