Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.

FDA Recall Z-0940-05 · Posted 2005-06-28

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2005-06-09
Date Terminated2005-09-21
Product Quantity1 unit

Reason for Recall

The reorder number listed on the product label is inaccurate.

Firm Action

Consignees were notified by email/fax on 06/17/2005.

Root Cause

Other

Distribution Pattern

Brazil, Japan & Hong Kong

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.

↑