Hot/cold gel packs: Updated urgent safety advisory, 17 September 2008

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Previous information

17 September 2008

A number of brands of hot/cold gel packs are being recalled following testing by the Therapeutic Goods Administration (TGA) of contents for ethylene glycol, a toxic substance. Testing was undertaken following the previous recall of Thermoskin® hot/cold gel packs to determine if the problem was more widespread.

All sponsors of gel hot/cold packs were contacted by the TGA to obtain information regarding the contents of their products and to obtain samples for testing. It has now been confirmed that some of these other products also contain ethylene glycol.

Several brands of gel hot/cold packs, listed below, are being recalled and the TGA website will be updated as further details of the affected products become available.

Notices advising consumers of these recalls will also appear in the media as soon as the sponsors of the affected products are able to obtain advertising space in national newspapers. In the meantime recall letters will be sent directly to pharmacies and other outlets selling the affected products.

The TGA reiterates that parents should ensure that all gel hot/cold packs are kept out of reach of children and are only used under adult supervision. In the event of accidental ingestion patients are urged to attend the nearest emergency department immediately for assessment and further management.

Sponsor Product description
3P Pty Ltd
(3 products)
  • Surgical Basics Hot / Cold Pack
    Item SB700, Small size 11x27 cm
  • Surgical Basics Hot / Cold Pack
    Item SB701, Large size 17x29 cm
  • SOFT R&R Hot/Cold Pack
    Item SB703
Brand Promotions
(1 product)
  • Hot & Cold Pack (labelled with 'Atacand® candesartan cilexetil' or 'Crestor® rosuvastatin')
    Supplied to health care professionals only
Eastland Medical
(7 products)
  • 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
Glenageary Pty Ltd
(1 product)
  • smartchoices™ Breast Soother®
Kendall (A Division of Tyco Healthcare Pty Ltd)
(6 products)
  • Surgipack Soft Hot/Cold Pack Large (Code 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)
Orthopaedic Appliances
(1 product)
  • OAPL Professional Reusable Hot and Cold Pack (on packaging), SOFT R&R Cold Hot Pack (on product)
Tinsonax NSW Pty Ltd
(2 products)
  • Medispot SOFT Hot/Cold Pack - Medium
  • Medispot SOFT Hot/Cold Pack - Large

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