—#121840

Product

Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.

FDA product code: NZA — Accessories, Germicide, Cleaning, For Endoscopes
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K040049, K102244, K110453
Affected lot / code info: Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 and MB000081. Serial number range 3625606001 - 3608912002

Why it was recalled

The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle.

Root cause (FDA determination)

Use error

Action the firm took

Steris sent an "URGENT PRODUCT SAFETY NOTICE" dated September 5, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AK, CO, FL, GA, HI, ID, IL, KS, LA, MD, MN, MO, MT, NE, NM, OH, PA, SC, UT, & WY and the countries of Australia, Canada & Spain.

Timeline

Recall initiated: 2013-08-29
Posted by FDA: 2013-09-20
Terminated: 2014-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.