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.
FDA Recall Z-0615-2009 · Posted 2009-01-16
Advertisement
Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeFQM
Date Initiated2008-11-18
Date Terminated2009-11-04
Product Quantity9,521 units (of all devices)
Reason for Recall
The natural rubber latex bandages were mislabeled as latex free.
Firm 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 and fax it to 847-689-9101. Please direct questions to Quality Systems, Professional Services at 800-292-9332.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide Distribution including USA, Guam and Korea.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement