Z-3041-2011

Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701...

Name: Z-3041-2011 Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701...
Creator: Steris Corporation
Published: 2011-08-01
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2011-08-01 / Terminated / root cause: sterility

FDA source

Steris Corporation began a recall of 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... on 2011-08-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-3041-2011
Status: Terminated
Initiated: 2011-08-01
Posted: 2011-08-19
Terminated: 2013-03-27
Recalling firm: STERIS Corporation
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.
Product code: MLR Sterilizer, Chemical
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.
Root cause tag: sterility
FDA root cause: Other
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.
Product codes and lots: Model #MLR, V-PRO 1: S/N 033250701 through S/N 031571106; V-PRO 1 Plus: S/N 031800801 through S/N 031581115

Product code MLR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)