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Terminated

Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

FDA Recall Z-1598-2009 · Posted 2009-07-21

Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeKNS
Date Initiated2009-06-12
Date Terminated2010-04-06
Product Quantity20 units

Reason for Recall

The wire control port of these devices may be missing due to omission of a manufacturing activity.

Firm Action

The distributor (Cook Ireland) was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Contact the Customer Quality Assurance Department at Cook Endoscopy for more information at [email protected] or 1-336-744-0157.

Root Cause

Process control

Distribution Pattern

International Distribution - Italy, Netherlands, Germany and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052051OMNI SPHINCTEROTOMEWilson-Cook Medical, Inc. · 2005-08-05

Official Source

View FDA Recall →

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

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