Z-0164-06

Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in...

Name: Z-0164-06 Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in...
Creator: Cardinal Health
Published: 2005-10-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-10-03 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health began a recall of Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL... on 2005-10-03. The reason FDA records is "The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex". 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-0164-06
Status: Terminated
Initiated: 2005-10-03
Posted: 2005-11-18
Terminated: 2006-12-21
Recalling firm: Medtronic, Inc.
Product: Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: a) Cat. PO23AAMCC - Arthroscopy Kit b) Cat. PO23TKMCC - Total Knee Kit c) Cat. SOP11OPFGB - Ortho Pack d) Cat. SCV48CVJHD - Strl Open Heart Part A & B Pk
Product code: LRO General Surgery Tray
Reason for recall: The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Cardinal Health notified the accounts who ordered the affected packs via letter dated 10/3/05, informing them that the packs that were labeled latex-free actually contained an elastic bandage that contained latex rubber. The letters were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to telephone Cardinal Customer Service at 1-800-964-5227 for return instructions for the affected packs return to Cardinal Health for replacement.
Distribution: South Carolina, New York, Nebraska, Florida and internationally to Canada
Product codes and lots: Cat. PO23AAMCC, order numbers 641370 and 655171; Cat. PO23TKMCC, order numbers 637245 and 639306; Cat. SOP11OPFGB, order numbers 640349, 641634, 644009, 651563 and 653696; Cat. SCV48CVJHD, order numbers 722851 and 728463.

Product code LRO

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)