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Terminated

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

FDA Recall Z-0164-06 · Posted 2005-11-18

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeLRO
Date Initiated2005-10-03
Date Terminated2006-12-21

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.

Firm 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.

Root Cause

Other

Distribution Pattern

South Carolina, New York, Nebraska, Florida and internationally to Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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