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Terminated

Biliary Stent Introducer Set

FDA Recall Z-0908-04 · Posted 2004-07-20

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2004-04-21
Date Terminated2004-08-17
Product Quantity23 pieces

Reason for Recall

The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.

Firm Action

Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor .

Root Cause

Other

Distribution Pattern

MO, NY, PA, Australia, Israel and England

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K851962ZIMMON BILIARY STENT SETWilson-Cook Medical, Inc. · 1985-12-17

Official Source

View FDA Recall →

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

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