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U.S. Department of Health and Human Services

Class 2 Device Recall ATLAS Loading Car

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  Class 2 Device Recall ATLAS Loading Car see related information
Date Initiated by Firm December 26, 2018
Create Date February 13, 2019
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-0824-2019
Recall Event ID 82023
510(K)Number K082435  K091136  
Product Classification Sterilizer, steam - Product Code FLE
Product ATLAS Loading Car
Code Information 32611805 32701812 32621831 33101809 32611806 32821802 32891819 32901805 32611807 32821803 32901806 32951813 32611811 32811817 32981817 33041801 32611812 32821804 32981818 33041831 32611810 32821805 32701826 33111804 32611813 32771805 32761815 33161840 32611809 32761816 32901802 32901803 32621813 32771804 32981815 32901804 32621814 32811816 32981819 33021823 32671801 32631816 32981822 33111806 32671802 32631818 32631817 32761818 32611808 32631820 32631821 32761820 32611814 32891817 32631822 32911810 32621815 32621834 32761819 33051806 32621816 32741821 32761821 33101808 32621833 32741822 32891815 32631823 32631825 32771806 32901809 32841801 32701827 32881806 32771803 32841802 32621812 32901808 33041833 32901801 32631824 32901810 33041834 32951812 32631826 32841804 32911807 32981823 32631827 32911809 32911808 33021824 32741815 32891813 32981816 33041802 32741818 32891814 33041832 33041803 32741823 32891816 33041830 33041804 32741843 32621830 32981820 33041829 32741817 32631819 32981821 33051804 32741819 32841803 33021825 33051805 32741816 32881803 33021826 33111805 32741820 32881804 32881805 33111807 32701811 32891818 32901807 33161839 33051803
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Ms. Katie Bias
440-392-7464
Manufacturer Reason
for Recall		 The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side.
FDA Determined
Cause 2		 Device Design
Action On December 20, 2018, the firm distributed Urgent Device Field Correction letters to its customers, informing them of the recall. Customers were advised of the following actions: 1. A Steris Service Technician will contact your facility to repair your units. 2. Users can continue to use the loading car and transfer carriage prior to repair. Users are advised to use caution when operating the loading car and transfer carriage, especially when the loading car is empty. If you have questions regarding this matter, please contact Sam Watkins, Senior Product Manager, at 440-392-7683, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.
Quantity in Commerce 129
Distribution Nationwide domestic distribution. Foreign distribution to Canada, Costa Rica, Indonesia, South Korea, and Taiwan.
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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