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Terminated

Zilver Expandable Metal Biliary Stent

FDA Recall Z-1181-03 · Posted 2003-08-26

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2002-01-08
Date Terminated2005-03-21
Product Quantity57 units

Reason for Recall

The inner catheter of the introducer system may break after stent deployment.

Firm Action

Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.

Root Cause

Other

Distribution Pattern

The product was distributed to hospitals located nationwide and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020788WILSON-COOK ZILVER BILIARY STENTWilson-Cook Medical, Inc. · 2002-05-08

Official Source

View FDA Recall →

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

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