FDA Recall Terminated

ATLAS Loading Car

Recall: Z-0824-2019 · Initiated December 26, 2018

Recall

Recall Number
Z-0824-2019
Event Number
82023
Firm
Steris Corporation
FEI Number
1527821
Product Code
FLE
Status
Terminated
Root Cause
Device Design
Initiated
December 26, 2018
Terminated
June 16, 2020
Address
5960 Heisley Rd, Mentor, OH, 44060-1834

Description

ATLAS Loading Car

Reason

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.

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.

Distribution

Nationwide domestic distribution. Foreign distribution to Canada, Costa Rica, Indonesia, South Korea, and Taiwan.

Quantity

129