FDA-Device2012-09-12Class II
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.
Breg Inc, An Orthofix Company
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.
Sold states
Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Affected count
502 units
Manufactured in
2885 Loker Ave E, N/A, Carlsbad, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2012Don't want to check this manually?
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