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Terminated

Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

FDA Recall Z-0520-2007 · Posted 2007-02-22

Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeKNQ
Date Initiated2007-01-24
Date Terminated2012-07-26
Product Quantity12 units

Reason for Recall

The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.

Firm Action

Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.

Root Cause

Other

Distribution Pattern

Worldwide, including NY and TX in USA, Australia, Canada and India.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935094BALLOON DILATION CATHETERWilson-Cook Medical, Inc. · 1995-01-24

Official Source

View FDA Recall →

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

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