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Recall Observatory FDA recall evidence

Device product

AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.

Z-0478-2014

October 18, 2013

Class II

Product summary

Firm
Steris Corporation
Event
Event 66874
Status
Terminated
Classification
Class II
Quantity
936 units
Official record key
device-enforcement:Z-0478-2014

Official wording

Reason: The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.

Code information: Serial Number Range: 030061103 - 0535531220

Distribution pattern: Worldwide Distribution - USA Nationwide in the states of: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MI, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and the District of Columbia including the countries of: Brazil, Canada, Chile, Guam, Mexico, Saudi Arabia, United Arab Emirates & Venezuela.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.