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Terminated

Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

FDA Recall Z-0347-04 · Posted 2004-01-14

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2003-12-22
Date Terminated2004-03-23
Product Quantity198 units

Reason for Recall

Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm

Firm Action

Consignee was notified by letter sent via fax on 12/19/2003.

Root Cause

Other

Distribution Pattern

Product was shipped to one distributor in Japan.

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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