Date Initiated by Firm |
August 11, 2010 |
Date Posted |
September 06, 2012 |
Recall Status1 |
Terminated 3 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 CA 92010-6626
|
For Additional Information Contact |
800-321-0607
|
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 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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