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Hot & cold packs - Kendall

Medical device recall
Published
Level: Consumer
Class: I
Reference: RN-2008-0756
Date agreed: 15 September 2008
Product: Surgipack SOFT hot/cold pack - Large (Product #6230)
Surgipack Soft Hot/Cold Pack Small (Code 6231)
Surgipack Soft Reusable Eye Mask Hot/Cold Pack (Code 6234)
Surgipack Flexible Hot/Cold Pack (Code 6227)
Body Plus Reusable Cold-Hot Pack Regular Size (Code BP1001)
Body Plus Reusable Cold-Hot Pack Super Size (Code BP1002)
ARTG number: 99853
Sponsor: Kendall (A Division of Tyco Healthcare Pty Ltd)
Contact: 1800 252 467
Reason: These products contains the toxic substance ethylene glycol (rather than the non-toxic ingredient propylene glycol).
Recall letters are being dispatched by the sponsor to customers from Wednesday 17 September 2008. Recall notices advising consumers of this recall will appear in the media as soon as the sponsor of Surgipack and Body Plus 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.

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