Recall Z-0615-2009 ยท FQM Bandage, Elastic
Cardinal Health
Esmark Elastic Bandage, 3" x 4 yards, sterile, for single use only, latex free. Distributed by Cardinal Health, McGaw Park, IL 60085-6787. The device is used to promote blood flow from the extremities by compressing the superficial vessels.
| Date | Jan 16, 2009 (initiated Nov 18, 2008) |
| Status | Terminated |
| Reason | The natural rubber latex bandages were mislabeled as latex free. |
| Root cause | Labeling Change Control |
| Action | A recall letter dated 11/17/08 was issued to the Directors of Materials Management and sent via DHL 2-day service on 11/18/08. Accounts were advised that the elastic bandages containing latex were mislabeled as latex free. Customers were requested to return their inventories of the affected product to Cardinal Health for credit or replacement by calling the Presource Customer Sales Operations Group at 800-766-0706 for return instructions. Customers were also requested to complete the enclosed Cardinal Customer Acknowledgement form by indicating the amount of affected product being returned |
| Quantity | 9,521 units (of all devices) |
| Distribution | Worldwide Distribution including USA, Guam and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.