Hanaulux Sterilizable Handle Hub (2019-12-17)

Starting date:

December 17, 2019

Posting date:

January 20, 2020

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-72117

Last updated: 2020-01-21

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  Reason
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  Affected products

Affected Products

Hanaulux Sterilizable Handle Hub

Reason

When inserting or removing the "Hanaulux" sterilizable handle to its support, the locking mechanism may break apart, if the c-clip that retains the metal axis is broken. Parts can fall if this happens: fragments of the c-clip, the locking mechanism or parts of it, e.g. spring, metal axis. During investigation, corrosion was observed on broken circlips. It was not possible to pin down the exact root cause for the corrosion, but the most probable root cause is the use of very aggressive cleaning products.

Affected products