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U.S. Department of Health and Human Services

Class 2 Device Recall Steris

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  Class 2 Device Recall Steris see related information
Date Initiated by Firm October 22, 2019
Create Date November 29, 2019
Recall Status1 Terminated 3 on June 09, 2020
Recall Number Z-0586-2020
Recall Event ID 84229
510(K)Number K082435  K091731  K112055  
Product Classification Sterilizer, steam - Product Code FLE
Product Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
Code Information Serial Numbers: 30021901 30031931 30031932 30031933 30031934 30031935 30091907 30091908 30101924 30101925 30101926 30101927 30101928 30101929 30101930 30121904 30121905 30121906 30151916 30151917 30151918 30151919 30151920 30161906 30161907 30161908 30161909 30171901 30171913 30171914 30171915 30171916 30221915 30221917 30231906 30231907 30231942 30231943 30231944 30231945 30251906 30251919 30251920 30251923 30251924 30251925 30251926 30251927 30281925 30281926 30281927 30291901 30301915 30301916 30301917 30301933 30301934 30311924 30311925 30311926 30311938 30311939 30361901 30361902 30361903 30371901 30371902 30371918 30381916 30381917 30381918 30381919 30381920 30381921 30381922 30421926 30421927 30421930 30421931 30431918 30431919 30441901 30441902 30441903 30441904 30441905 30441906 30441912 30441929 30441930 30441931 30501909 30501910 30501911 30601931 30601932 30661917 30701913 30731914 30731915 30731916 30781915 30781916 30781917 30781918 30781919 30781920 30781921 30791904 30801902 30801904 30851932 30851934 30861906 30871903 30881901 30881902 30881903 30881904 30881905 30881906 30881907 30881908 30881909 30881910 32761834 32761835 32761836 32761837 32761838 32761839 32771813 32841823 32841824 32841825 32841826 32841827 32841828 32841829 32841830 32841831 32891830 32891831 32901821 32901822 32901823 32901824 32901825 32901826 32911801 32911803 32911804 32951824 32951825 32951826 32951829 32981801 32981802 32981803 32981804 32981805 32981806 33041817 33041818 33041819 33041849 33041850 33041851 33041852 33051813 33051814 33101816 33101817 33111812 33111826 33111827 33111828 33111829 33161826 33161827 33161828 33161829 33181813 33181814 33181815 33181816 33211807 33211808 33211809 33261824 33261825 33261826 33261827 33281815 33281816 33301801 33301811 33301812 33321833 33321834 33321835 33331811 33331812 33331813 33381814 33381815 33401808 33401809 33401810 33401811 33441827 33441828 33441829 33441830 33451803 33451804 33451805 33471829 33471830 33471831 33471832 33471833 33511811 33511812 33521827 33521828 33541802 33541823 33541824 33541825 33541826 33541827 33541828 33601816 33631801 33631802 33631815 
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact SAME
440-392-7601
Manufacturer Reason
for Recall
The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward
FDA Determined
Cause 2
Process control
Action Steris Corp. issued URGENT DEVICE FIELD CORRECTION dated 10/22/19 informing users reason for recall, and action to take: A STERIS Service Technician will contact your facility to repair your unit(s). Users can continue to use the transfer carriage prior to this repai r. Users are advised to use caution when operating the transfer carriage, and avoid bumping into other equipment or rolling over uneven surfaces. If you have questions regarding this matter, please contact STERIS Technical Support, at 800-333-8828, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.
Quantity in Commerce 237 units
Distribution Nationwide Foreign: Canada, Peru, Mexico, Brazil, Saudi Arabia, Columbia
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = FLE and Original Applicant = STERIS Corporation
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