—#74942

Product

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.

FDA product code: FQM — Bandage, Elastic
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Catalog number 23580-043: Work order numbers 310652, 316815, 324060 and 327413.

Why it was recalled

The natural rubber latex bandages were mislabeled as latex free.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Worldwide Distribution including USA, Guam and Korea.

Timeline

Recall initiated: 2008-11-18
Posted by FDA: 2009-01-16
Terminated: 2009-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74942. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.