Medilas D Laser System - Optical Fiber, Laser Fiber Light Guides (2019-04-27)

Starting date:

April 27, 2019

Posting date:

June 14, 2019

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-70189

Last updated: 2019-06-14

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  Reason
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  Affected products

Affected Products

A. Medilas D Laser System - Optical Fiber

B. Laser Fiber Light Guides

Reason

During a routine re-evaluation of the packaging design for the diode fibers conducted to confirm a 5 year shelf life, test results indicated that the current package design, paper/poly pouch, showed pin hole package failures indicating that the packaging design is highly vulnerable to mechanical stress, leading to it not meeting the specified shelf-life of five years.

Affected products