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Amsco Evolution Steam Sterilizers (2013-10-18)
- Starting date:
- October 18, 2013
- Posting date:
- February 11, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37865
Recalled Products
- Amsco Evolution Prevacuum Steam Sterilizer
- Amsco Evolution SFPP Steam Sterilizer
Reason
The Amsco Evolution steam sterilizers utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. Off-label use of transfer carriages by customers is resulting in minor injuries such as strained backs. Despite repeated in-services, these injuries are occurring when operators are pushing/maneuvering carriages that have been overloaded or not loaded evenly.
Affected products
A. Amsco Evolution Prevacuum Steam Sterilizer
Lot or serial number
- 030061103 to 0535531220
Model or catalog number
- UE04-XXX-XXX-XXX
- UE05-XXX-XXX-XXX
- UE06-XXX-XXX-XXX
- UE24-XXX-XXX-XXX
- UE25-XXX-XXX-XXX
- UE26-XXX-XXX-XXX
- UE43-XXX-XXX-XXX
- UE44-XXX-XXX-XXX
Companies
- Manufacturer
-
Steris Mexico
790 Avante Ave., Industrial Park
Guadalupe, Nuevo Leon
67190
MEXICO
B. Amsco Evolution SFPP Steam Sterilizer
Lot or serial number
- 030061103 to 0535531220
Model or catalog number
- UE01-XXX-XXX-XXX
- UE02-XXX-XXX-XXX
- UE03-XXX-XXX-XXX
- UE21-XXX-XXX-XXX
- UE22-XXX-XXX-XXX
- UE23-XXX-XXX-XXX
- UE41-XXX-XXX-XXX
- UE42-XXX-XXX-XXX
Companies
- Manufacturer
-
Steris Mexico
790 Avante Ave., Industrial Park
Guadalupe, Nuevo Leon
67190
MEXICO