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Hot & cold packs - Westcoast Surgical and Medical Supplies

Medical device recall
Published
Level: Consumer
Class: I
Reference: RN-2008-0748
Date agreed: 15 September 2008
Product: REDI™ Eye Mask Hot/Cold Pack
REDI™ Full Face Mask Hot/Cold Pack
REDI™ Face mask Hot/Cold Pack
REDI™ Hot/Cold Pack - small dual colour
REDI™ Hot/Cold Pack with compression wrap - small dual colour
REDI™ Hot/Cold Pack - small PVC Frosty Bear™
REDI™ Hot/Cold Pack
ARTG number: 116111
Sponsor: Westcoast Surgical and Medical Supplies
Contact: 08 9455 6676 Westcoast Surgical and Medical Supplies
Reason: These products contains the toxic substance ethylene glycol (rather than the non-toxic ingredient propylene glycol).
Recall letters will be dispatched by the sponsor to hospitals and physiotherapists from Wednesday 17 September 2008. Recall notices advising consumers of this recall will appear in the media as soon as the sponsor of the Hot/Cold Packs 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