Z-0615-2009

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

Name: Z-0615-2009 Esmark Elastic Bandage, 3" x 4 yards, sterile, for single use only, latex free. Distributed by Cardinal...
Creator: Cardinal Health
Published: 2008-11-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-11-18 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health began a recall of 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... on 2008-11-18. The reason FDA records is "The natural rubber latex bandages were mislabeled as latex free". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0615-2009
Status: Terminated
Initiated: 2008-11-18
Posted: 2009-01-16
Terminated: 2009-11-04
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: FQM Bandage, Elastic
Reason for recall: The natural rubber latex bandages were mislabeled as latex free.
Root cause tag: labeling and UDI
FDA 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 and fax it to 847-689-9101. Please direct questions to Quality Systems, Professional Services at 800-292-9332.
Quantity in commerce: 9,521 units (of all devices)
Distribution: Worldwide Distribution including USA, Guam and Korea.
Product codes and lots: Catalog number 23580-034: Work order numbers 304696 and 312977.

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)