Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexi

FDA device recall Z-1190-2008 · posted 2008-08-05 · Terminated

Recall details

Recalling firm

Steris Corp

Reason for recall

Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The L6 sensor fails to alarm when the high pressure pump is not working properly.

Action taken

Steris sent an Urgent Safety Alert/Recall letter dated 2/8/2008, to all customers. The letter stated that any device sterilized in the C1160 Tray should not be used clinically prior to a completion of a successful diagnostic cycle. Until further notice, you must run a diagnostic cycle after each sterile cycle involving a C1160 tray or alternately you must discontinue use of these trays. Steris service technicians will schedule visits to correct the problem.

Root cause

Device Design

Status

Terminated

Product code

MED

Quantity affected

28,766 units

Distribution

Worldwide Distribution, including USA, Puerto Rico, Canada, and Japan.

Date initiated

2008-02-19

Date posted

2008-08-05

Date terminated

2012-02-24

Location

Mentor, OH