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Thermoskin® hot/cold gel pack (blue)

Medical device recall

2 September 2008
Level: Consumer
Class: I
Reference: RN-2008-0701
Date agreed: 02 September 2008
Product:

Thermoskin® hot/cold gel pack (blue):

Small (20cm x 13cm)
Medium (30cm x 13cm) and
Large (37cm x 18cm)

Product codes 86901, 86902 and 86903

ARTG number: 109477
Sponsor: United Pacific Industries Pty Ltd
Contact: 1800 188 019 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 on Wednesday 3 September 2008. Recall notices advising consumers of this recall will appear in the media as soon as the sponsor of Thermoskin® 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.