AMSCO 400 SERIES STERILIZER (2015-03-09)

Starting date:

March 9, 2015

Posting date:

April 14, 2015

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-52909

• 
  Reason
• 
  Affected products

Recalled Products

A. AMSCO 400 SERIES MEDIUM STEAM STERILIZER

B. AMSCO 400 SERIES PREVACUUM SMALL STEAM STERILIZER

C. AMSCO 400 SERIES STEAM FLUSH PRESSURE PULSE SMALL STEAM STERILIZER

Reason

Steris has identified the control board software in select AMSCO 400 units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay should the facility immediately require instruments from the cancelled processing cycle. If the processing cycle is interrupted the cycle should not be considered complete and the instruments should be reprocessed. Steris has received no reports of procedure delays associated with the occurrence of these events.

Affected products