EEA Hemorrhoid and Prolapse Stapler Set with DST (2018-04-09)

Starting date:

April 9, 2018

Posting date:

May 1, 2018

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-66622

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  Reason
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  Affected products

Affected products

EEA Hemorrhoid and Prolapse Stapler Set with DST

Reason

Recall initiating due to the potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. This issue was identified during in-process quality testing at the manufacturing facility.

Affected products