The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in

FDA device recall Z-1522-2012 · posted 2012-05-11 · Terminated

Recall details

Recalling firm

Steris Corporation

Reason for recall

Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer carriage due to the following issues with the transfer carriage. 1) Deformation of the latch pin or cracked ball bearings preventing the roller from turning. 2) The rollers on the ends of the pivot a

Action taken

Steris Corporation sent an Urgent Voluntary Field Correction Notice dated March 23, 2012 via FedEx with tracking numbers for delivery confirmation to each affected customer. The letter identified the affected product, problem and actions to be taken. The letter stated a STERIS Field Service Representatives will contact each affected customer to schedule a service visit to upgrade the transfer carriages. For technical questions or questions regarding STERIS visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Root cause

Device Design

Status

Terminated

Product code

FLE

Quantity affected

523

Distribution

Worldwide Distribution - USA Nationwide including AL, AZ, CA, CO, CN, DE, FL, GA, IL, IN, KA, KY, LA, MD, MA, MI, ME, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, &

Date initiated

2012-03-23

Date posted

2012-05-11

Date terminated

2013-06-11

Location

Mentor, OH

Related 510(k) clearances