Esmark Elastic Bandage, 4" x 3 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.
This recall has been terminated (originally issued January 16, 2009).
- Company
- Cardinal Health
- Recall Initiated
- November 18, 2008
- Posted
- January 16, 2009
- Terminated
- November 4, 2009
- Recall Number
- Z-0616-2009
- Quantity
- 9,521 units (of all devices)
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The natural rubber latex bandages were mislabeled as latex free.
Distribution
Worldwide Distribution including USA, Guam and Korea.
Lot / Code Info
Catalog number 23580-043: Work order numbers 310652, 316815, 324060 and 327413.
Root Cause
Labeling Change Control
Action Taken
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 and fax it to 847-689-9101. Please direct questions to Quality Systems, Professional Services at 800-292-9332.