AMSCO V-PRO 1, AMSCO V-PRO 1 Plus, and AMSCO V-PRO maX Low Temperature Sterilization System (2018-07-23)

Starting date:

July 23, 2018

Posting date:

July 27, 2018

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-67316

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  Reason
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  Affected products

Affected products

A. AMSCO V-PRO 1 Low Temperature Sterilization System

B. AMSCO V-PRO 1 Plus Low Temperature Sterilization System

C. AMSCO V-PRO maX Low Temperature Sterilization System

Reason

The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems with VAPROX HC Sterilant (DIN# 02303604) are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and non-metal medical devices in healthcare facilities. The sterilization cycles operate at low pressure and temperature, suitable for processing medical devices sensitive to heat and moisture. Steris has identified that in the unlikely scenario where a punctured cup of VAPROX HC Sterilant expires while the V-PRO Unit (1, 1 Plus, or maX) is powered down, upon power-up the V-PRO Unit will not detect the expired cup of Sterilant; allowing for subsequent cycles to be run. Steris's VAPROX Sterilant microbial efficacy studies support a safety margin for use of the product for three (3) days after the indicated in-use expiry date. Steris has not received any reports of adverse events related to the issue described above.

Affected products