Fusion OMNI Tome Preloaded Sphincterotome (2015-01-28)

Starting date:

January 28, 2015

Posting date:

February 16, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-43727

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  Reason
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  Affected products

Recalled Products

A) Fusion OMNI Tome Preloaded Sphincterotome

Reason

The wire guide in the fusion OMNI-tome preloaded Sphincterotome being loaded incorrectly into the device resulting in the incorrect end of the wire guide exiting the Sphincterotome. The preloaded wire guide has a black floppy distal tip which could be located at the proximal/user end and leaving the stiff end of the wire guide at the distal/patient end of the Sphincterotome.  Difficulty advancing the wire guide may be experienced.

Affected products