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.
FDA Recall Z-2326-2012 · Posted 2012-09-06
Recalling FirmBreg Inc, An Orthofix Company
Recall StatusTerminated
Product CodeKGX
Date Initiated2010-08-11
Date Terminated2012-09-06
Product Quantity502 units
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.
Firm Action
The firm, Breg Orthofix, called their customers on August 11, 2010 sent a letter dated August 12, 2010 and emails to all customers. The call and letter described the product, problem and actions to be taken. The customers were instructed to take immediate action to identify and quarantine the product at their facility. Breg established a return materials authorization and is contacting their customers to provide a Return Authorization to return the dressings. Breg is also providing replacement dressings.
If you have any questions regarding communication or the Intelli-Flo Sterile Dressing, contact Breg Customer Relations at (800) 321-0607.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.