Recall Z-2263-2013— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2013-08-29, terminated 2014-07-03. It names 3 FDA 510(k) clearances: K110453, K102244, K040049. 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.. Reason: 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-29
- Terminated
- 2014-07-03
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K110453 — RELIANCE ENDOSCOPE PROCESSING SYSTEM
- K102244 — RELIANCE ENDOSCOPE PROCESSING SYSTEM
- K040049 — THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.