FDA Device

Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614.

Hazard

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

What You Should Do

Remedy

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.

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Products

Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Brand
Edwards Lifesciences, Llc
UPC
Lot Numbers: FR6F0111 (Exp 2008/06), FR6G0120 (Exp 2008/08), FR6G0121 (Exp 2008/08), FR6H0135 (Exp 2008/08), FR6H0182 (Exp 2008/08) and FR6H0192 (Exp 2008/08)

Units Affected

Lot Code FR6F0111 - 1 UNIT, FR6G0120 - 3 UNITS, FR6G0121 - 4 UNITS, FR6H0135 - 2 UNITS, FR6H0182 - 5 UNITS, FR6H0192 - 3 UNITS

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