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Recall Observatory FDA recall evidence

Device product

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.

Z-2326-2012

August 11, 2010

Class II

Product summary

Firm
Breg Inc, An Orthofix Company
Event
Event 58247
Status
Terminated
Classification
Class II
Quantity
502 units
Official record key
device-enforcement:Z-2326-2012

Official wording

Reason: 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.

Code information: Lot # D101564

Distribution pattern: Worldwide distribution: USA (nationwide) and country of: Nova Scotia.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled