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Health product recall

GETINGE WASHER/DISINFECTOR (2015-10-10)

Starting date:
October 10, 2015
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-55760

Affected Products

GETINGE WASHER/DISINFECTOR

Reason

Getinge received two complaints that sediment residuals were found in the manifold of Getinge 46 Series Washer/Disinfectors with the drying option and PACS 300 controls. Investigation revealed that there was insufficient water flow through the manifold, which allowed air pockets to occur.

Affected products

GETINGE WASHER/DISINFECTOR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 46-2
  • 46-4
  • 46-5
Companies
Manufacturer
Getinge Disinfection AB
LJUNGADALSGATAN 11
VAXJO
35115
SWEDEN