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.
FDA Recall Z-0478-2014 · Posted 2013-12-11
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Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFLE
Date Initiated2013-10-18
Date Terminated2014-05-13
Product Quantity936 units
Reason for Recall
The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
Firm Action
Steris sent an Urgent Voluntary Field Correction Notice letter dated October 18, 2013 to their customers. The letter identified the affected product, problem, and actions to be taken. The letter informed customers that a Steris Service Representative will contact affected facility to arrange for Steris to upgrade the Transfer Carriage(s). For questions contact Steris Field Service Dispatch at 1-800-333-8828.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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