Recall Z-2326-2012 ยท KGX Tape And Bandage, Adhesive
Breg Inc, An Orthofix Company
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.
| Date | Sep 6, 2012 (initiated Aug 11, 2010) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 502 units |
| Distribution | Worldwide distribution: USA (nationwide) and country of: Nova Scotia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.