—#103262

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.

FDA product code: MEC — Disinfector, Medical Devices
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Model #: 1802983

Why it was recalled

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.

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-05-09
Posted by FDA: 2011-09-01
Terminated: 2013-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103262. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.