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Terminated

Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam

FDA Recall Z-0586-2020 · Posted None

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFLE
Date Initiated2019-10-22
Date Terminated2020-06-09
Product Quantity237 units

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

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Foreign: Canada, Peru, Mexico, Brazil, Saudi Arabia, Columbia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112055AMSCO CHIMERON MEDIUM STEAM STERILIZERSTERIS Corporation · 2011-12-16K091731AMSCO EVOLUTION MEDIUM STEAM STERILIZERSTERIS Corporation · 2009-09-17K082435AMSCO 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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