Recall Z-2326-2012— Breg Inc, An Orthofix Company
Class II · Terminated
Class II FDA medical device recall by Breg Inc, An Orthofix Company, initiated 2010-08-11, terminated 2012-09-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Breg Inc, An Orthofix Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2010-08-11
- Terminated
- 2012-09-06
- Firm location
- Carlsbad, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.