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Recall Observatory FDA recall evidence

Device product

The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.

Z-2122-2012

July 14, 2012

Class II

Product summary

Firm
Steris Corporation
Event
Event 62557
Status
Terminated
Classification
Class II
Quantity
367
Official record key
device-enforcement:Z-2122-2012

Official wording

Reason: To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be installed on your cart washer.

Code information: The codes for the product are Julian date-coded. They follow the following pattern: AABBBCCDDD AA is a two digit code representing the manufacturing facility number BBB is a three digit code representing the day of the year that the device was manufactured CC is a two digit code representing the Julian year that the device was manufactured DDD is a three digit code representing the number of the number of the device manufactured that day. For example, a serial number of 3606499005 indicates that the device was manufactured in facility number 36, on the 64th day of the year of 1999, and the device was the 5th device manufactured that day. The serial number ranges for the devices being recalled are: RELIANCE¿ 130: 3606499005  3626709006 RELIANCE¿ 130L: 3629299006  3628809011

Distribution pattern: Worldwide Distribution -- USA (nationwide) including the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. and the countries of : Australia, South Korea, France, Italy, Lebanon, Russia, Saudi Arabia, Spain, UAE, United Kingdom and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close confirmation button and door open delay will be installed on your cart washer.