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
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
Hanaulux Sterilizable Handle Hub
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- ARD568303905
- ARD568330951
- ARD568330953
- ARD568334999
- ARD568335999
- ARD568350904
- ARD568350905
- ARD568350951
- ARD568350953
- ARD568350958
- ARD568350959
- ARD568370955
- ARD568370958
- ARD568370959
Companies
- Manufacturer
-
Maquet S.A.
Avenue de la Pomme De Pin, Parc De Limere
Ardon, Orleans
45074
FRANCE