Health product recall

AMSCO 5052 Single-Chamber Washer/Disinfector (2018-12-23)

Starting date:
December 23, 2018
Posting date:
January 23, 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-68840

Affected products

AMSCO 5052 Single-Chamber Washer/Disinfector

Reason

STERIS has identified that the software in the AMSCO 3052 and 5052 Single-Chamber Washer/Disinfectors equipped with an automated SCS Conveyor and barcode system may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.

Affected products

AMSCO 5052 Single-Chamber Washer/Disinfector

Lot or serial number
  • S/N: 3601518012
  • S/N: 3603618005
  • S/N: 3612718013
  • S/N: 3632318009
  • S/N: 3601518006
Model or catalog number
  • FH14-043
  • FH14-072
  • FH14-XXXX
Companies
Manufacturer

Steris Canada Corporation

490 Boul. Armand-Paris

Quebec

G1C 8A3

Quebec

CANADA