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U.S. Department of Health and Human Services

Class 2 Device Recall Reliance Vision Single Chamber Washer/Disinfector

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 Class 2 Recall
Reliance Vision Single Chamber Washer/Disinfector
see related information
Date Posted September 01, 2011
Recall Status1 Terminated on March 01, 2013
Recall Number Z-3118-2011
Recall Event ID 59570
Product Classification Disinfector, Medical Devices - Product Code MEC
Product Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities.
Code Information Model #: 1802983
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 Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action The firm, STERIS sent an "URGENT FIELD CORRECTION NOTICE" letter dated May 9, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed that they can continue using their Vision SC Washer(s) prior to installation of the system upgrades. The letter states that STERIS is correcting the issues by implementing a series of quality improvements to the customers Vision SC Washer(s) to ensure satisfaction. Additionally, a STERIS Service Representative will contact the customers facility to arrange for STERIS to upgrade their Vision SC Washer(s). For further information or if you have questions regarding the servicing of your unit, please contact STERIS Field Service Dispatch at 1-800-333-8828.
Quantity in Commerce 404 Units
Distribution Worldwide distribution: USA (nationwide) including states of: L, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI and WY; and countries of: Australia, Canada, Hong Kong and South Korea.
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.
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