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

FDA device recall Z-0163-06 · posted 2005-11-18 · Terminated

Recall details

Recalling firm
Cardinal Health
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.
Action taken
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
Status
Terminated
Product code
LRO
Distribution
South Carolina, New York, Nebraska, Florida and internationally to Canada
Date initiated
2005-10-03
Date posted
2005-11-18
Date terminated
2006-12-21
Location
McGaw Park, IL

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