Z-0163-06

Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in...

Name: Z-0163-06 Cardinal Health Custom Sterile 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 Custom Sterile 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-0163-06
Status: Terminated
Initiated: 2005-10-03
Posted: 2005-11-18
Terminated: 2006-12-21
Recalling firm: Medtronic, Inc.
Product: Cardinal Health Custom Sterile 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. POOCOTFGB - Sterile Ortho Pack b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack k) Cat. SOP30THDTD - Sterile Total Hip Pack l) Cat. SOP30THNOA - Sterile Total Hip Pk m) Cat. SOP30THSJA - Sterile Total Hip Pack n) Cat. SOP30TKSJA - Sterile Total Knee Pack o) Cat. SOP30THVCH - Sterile Total Hip Pack p) Cat. SOP30TKVCE - Sterile Total Knee Pack
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. POOCOTFGB, order numbers 9904815, 9911445, 9911446, 9923559, 9926928, 9929035 and 9932551; Cat.SOP22ARCLC, order number 144191; Cat. SOP30ARCOB, order number 704460; Cat. SOP30ARCOC, order numbers 713043 and 717623; Cat. SOP30ARKGC, order number 716550; Cat. SOP30ARMCB, order numbers 708643 and 717298; Cat. SOP30ARNOA, order number 728554; Cat. SOP30KANRA, order number 708579; Cat. SOP30LENHC, order numbers 702865 and 714615; Cat. SOP30SADTE, order number 717371; Cat. SOP30THDTD, order number 715392; Cat. SOP30THNOA, order number 728333; Cat. SOP30THSJA, order number 710742; Cat. SOP30TKSJA, order number 709389; Cat. SOP30THVCH, order numbers 709885 and 719564; Cat. SOP30TKVCE, order numbers 703408 and 716341

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)