| Class 2 Device Recall AMSCO Evolution steam sterilizer Transfer Carriage | |
Date Initiated by Firm | October 18, 2013 |
Date Posted | December 11, 2013 |
Recall Status1 |
Terminated 3 on May 13, 2014 |
Recall Number | Z-0478-2014 |
Recall Event ID |
66874 |
510(K)Number | K082435 K091136 |
Product Classification |
Sterilizer, steam - Product Code FLE
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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. |
Code Information |
Serial Number Range: 030061103 - 0535531220 |
Recalling Firm/ Manufacturer |
Steris Corporation 5960 Heisley Rd Mentor OH 44060-1834
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For Additional Information Contact | Mrs. Lindsey M. McGowan 440-392-7519 |
Manufacturer Reason for Recall | The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. |
FDA Determined Cause 2 | Device Design |
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. |
Quantity in Commerce | 936 units |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FLE
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