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U.S. Department of Health and Human Services

Class 2 Device Recall Amsco VPRO 1 and Amsco VPRO 1 Plus Low Temperature Sterilization Systems

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 Class 2 Recall
Amsco VPRO 1 and Amsco VPRO 1 Plus Low Temperature Sterilization Systems
see related information
Date Posted August 19, 2011
Recall Status1 Terminated on March 27, 2013
Recall Number Z-3041-2011
Recall Event ID 59520
Premarket Notification
510(K) Numbers
K062297  K083097 
Product Classification Sterilizer, Chemical - Product Code MLR
Product 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.
Code Information Model #MLR, V-PRO 1: S/N 033250701 through S/N 031571106; V-PRO 1 Plus: S/N 031800801 through S/N 031581115
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060
For Additional Information Contact Lindsey M. McGowan
440-392-7519
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Quantity in Commerce 663 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = STERIS CORPORATION
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