Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. T

FDA device recall Z-3041-2011 · posted 2011-08-19 · Terminated

Recall details

Recalling firm

Steris Corporation

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.

Action taken

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

Status

Terminated

Product code

MLR

Quantity affected

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,

Date initiated

2011-08-01

Date posted

2011-08-19

Date terminated

2013-03-27

Location

Mentor, OH

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