SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liqui

FDA device recall Z-0616-2014 · posted 2013-12-31 · Terminated

Recall details

Recalling firm

Steris Corporation

Reason for recall

Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.

Action taken

STERIS sent an Urgent Voluntary Field Correction Notice dated November 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that a STERIS Field Service Representative would contact their facility to schedule installation of the new hardware and updated software on their SYSTEM IE Liquid Chemical Sterilant Processing System(s). Customers were instructed that they may continue to operate the SYSTEM IE processor prior to the completion of the update. Customers with questions were instructed to contact STERIS Field Service Dispatch at 1-800-333-8828. For questions regarding this recall call 440-392-7519.

Root cause

Device Design

Status

Terminated

Product code

MLR

Quantity affected

6,028 units

Distribution

Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turk

Date initiated

2013-11-21

Date posted

2013-12-31

Date terminated

2014-06-16

Location

Mentor, OH

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