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Terminated

ATLAS Loading Car

FDA Recall Z-0824-2019 · Posted None

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFLE
Date Initiated2018-12-26
Date Terminated2020-06-16
Product Quantity129

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091136AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200STERIS Corporation · 2009-06-29K082435AMSCO EVOLUTION MEDIUM STEAM STERILIZERSTERIS Corporation · 2008-12-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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