RecallDepth

Biliary Stent Introducer Set

Company
Wilson-Cook Medical Inc
Recall Initiated
April 21, 2004
Posted
July 20, 2004
Terminated
August 17, 2004
Recall Number
Z-0908-04
Quantity
23 pieces
Firm Location
Winston Salem, NC

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.

Distribution

MO, NY, PA, Australia, Israel and England

Lot / Code Info

Reorder (catalog) number SIS-10, Lot number W1733880

Root Cause

Other

Action Taken

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

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