Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris
FDA device recall Z-2263-2013 · posted 2013-09-20 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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.
- Action taken
- 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.
- Root cause
- Use error
- Status
- Terminated
- Product code
- NZA
- Quantity affected
- 266 units
- Distribution
- 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.
- Date initiated
- 2013-08-29
- Date posted
- 2013-09-20
- Date terminated
- 2014-07-03
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RELIANCE ENDOSCOPE PROCESSING SYSTEM (K110453) | STERIS Corporation | 2011-03-16 |
| RELIANCE ENDOSCOPE PROCESSING SYSTEM (K102244) | STERIS Corporation | 2010-12-03 |
| THE RELIANCE ENDOSCOPE PROCESSING SYSTEM (K040049) | STERIS Corporation | 2004-12-17 |