FDAFDA · Food and drugs·Recall number Z-2326-2012
Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
Published September 12, 2012 · Recall initiated: August 11, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Breg Inc, An Orthofix Company
- Distributor
- Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
- Lot
- Lot # D101564
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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