Clip Gun System - Clip Gun (2017-12-18)

Starting date:

December 18, 2017

Posting date:

January 12, 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-65680

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  Reason
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  Affected products

Affected products

Clip Gun System - Clip Gun

Reason

Testing performed by Medtronic showed that the outer sterile pouch of the product did not meet standards for package integrity. Specifically, the testing demonstrated that the outer pouch could be compromised and possibly be undetected by the user, which could potentially lead to patient infections. In an abundance of caution, these affected products are being removed from the field.

Affected products