Device recall
Z-2263-2013: Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-2263-2013 |
|---|---|
| Recall event | 66247 |
| 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. |
| Product code | NZA |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 3, 2014 |
| 510(k) numbers | K040049, K102244, K110453 |
| FEI number | 1527821 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database