Esmark Elastic Bandage, 4" x 3 yards, sterile, for single use only, latex free. Distributed by Cardinal Health, McGaw Pa

FDA device recall Z-0616-2009 · posted 2009-01-16 · Terminated

Recall details

Recalling firm

Cardinal Health

Reason for recall

The natural rubber latex bandages were mislabeled as latex free.

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.

Root cause

Labeling Change Control

Status

Terminated

Product code

FQM

Quantity affected

9,521 units (of all devices)

Distribution

Worldwide Distribution including USA, Guam and Korea.

Date initiated

2008-11-18

Date posted

2009-01-16

Date terminated

2009-11-04

Location

Park, IL