Reported Jul 18, 2018 · Terminated

Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and…

Steris Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834

Is this the product you have?

  • Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102
  • FW03S003 Product UsageThe Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the care of patients
Lot codes and dates
  • 118 of 118 codes

    • 3632511020
    • 3634311005
    • 3607312011
    • 3615312001
    • 3611012005
    • 3627012001
    • 3626212001
    • 3633112020
    • 3632612001
    • 3601413013
    • 3629612014
    • 3602113013
    • 3605113001
    • 3615912011
    • 3606613001A
    • 3607413001
    • 3612713001
    • 3614913001
    • 3616213001
    • 3608613001
    • 3623313001
    • 3624113001
    • 3626813001
    • 3627313019
    • 3628113001
    • 3628213002
    • 3629113001
    • 3631613011
    • 3635013015
    • 3601514001
    • 3603614001
    • 3604114024
    • 3604914002
    • 3630113020
    • 3613214010
    • 3611814020
    • 3616714023
    • 3630813004
    • 3628214010
    • 3629414002
    • 3630814002
    • 3631614001
    • 3631414016
    • 3632914001
    • 3632414003
    • 3634914022
    • 3604415042
    • 3605415029
    • 3606115033
    • 3604715027
    • 3608215021
    • 3615215026
    • 3613915001
    • 3619415002
    • 3623015006
    • 3623715001
    • 3627115035
    • 3627315001
    • 3627815020
    • 3629215021
Amount recalled
118

Where it was sold

Why it was recalled

The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from initiating a cycle when a low chemical level situation occurs, does not operate as intended. Currently, if a low chemical level situation occurs, the alarm will only be generated at the unit s next power-up or when accessing service mode. The failure of the Reliance 1227 to identify that the chemicals used for cleaning are low or empty could result in bedpans and urinals, basins, case carts, beds, theater shoes and other miscellaneous reusable patient care items not being properly cleaned before disinfection or reuse.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 5, 2019 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.