—#67981

Product

Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080303CD; Edwards Lifesciences LLC, Irvine, CA 92614.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K053404
Affected lot / code info: Lot Number: FR6H0155

Why it was recalled

Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, Llc
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2007-12-05
Posted by FDA: 2008-07-02
Terminated: 2012-01-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.