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U.S. Department of Health and Human Services

Class 2 Device Recall INTELLIFLO DRESSING

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 Class 2 Recall
INTELLIFLO DRESSING
see related information
Date Posted September 06, 2012
Recall Status1 Terminated on September 06, 2012
Recall Number Z-2326-2012
Recall Event ID 58247
Product Classification Tape And Bandage, Adhesive - Product Code KGX
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.
Code Information Lot # D101564
Recalling Firm/
Manufacturer
Breg Inc, An Orthofix Company
2885 Loker Ave E
Carlsbad, California 92010-6626
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 502 units
Distribution Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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