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Terminated

Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. The STERIS Amsco V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-contained stand alone devices, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices sensitive to heat and moisture.

FDA Recall Z-3041-2011 · Posted 2011-08-19

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMLR
Date Initiated2011-08-01
Date Terminated2013-03-27
Product Quantity663 units

Reason for Recall

STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device's chamber following a failed leak test.

Firm Action

Steris Corporation sent an URGENT VOLUNTARY FIELD CORRECTION NOTICE dated August 5, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. A STERIS Service Representative will contact your facility to arrange for STERIS to upgrade your V-PRO System(s). You can continue to use your system prior to the installation of the system upgrades. In the interim period should you experience any alarms or aborted cycles, the load must be handled in accordance with the Amsco V-PROTM 1 and V-PROTM 1Plus Low Temperature Sterilization Systems Operators Manual and your internal hospital procedures. For further information or if you have questions regarding this matter, please contact Field Service Dispatch at 1-800-333-8828.

Root Cause

Other

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including the states of: AK, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV & WY, and countries of: Australia, Bangladesh, Belgium, Belarus, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, India, Iraq, Ireland, Italy, Japan, Kuwait, Lebanon, Mexico, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Turkey, Vietnam, United Arab Emirates, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083097AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation · 2009-08-03K062297VHP 136 LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation · 2007-10-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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