Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100201CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall Z-1288-2008 · Posted 2008-07-02
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Recalling FirmEdwards Lifesciences, Llc
Recall StatusTerminated
Product CodeFGE
Date Initiated2007-12-05
Date Terminated2012-01-11
Product Quantity2 UNITS
Reason for Recall
Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.
Firm Action
Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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