—#123916

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.

FDA product code: FLE — Sterilizer, Steam
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K082435, K091136
Affected lot / code info: Serial Number Range: 030061103 - 0535531220

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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.

Timeline

Recall initiated: 2013-10-18
Posted by FDA: 2013-12-11
Terminated: 2014-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123916. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.