Device recall
Z-0037-2011: HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection…
FDA device recall · Class II · Cenorin
Key facts
| Recall number (Z-number) | Z-0037-2011 |
|---|---|
| Recall event | 55802 |
| Product | HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater. Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD… |
| Product code | LDS |
| Recalling firm | Cenorin |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2012 |
| FEI number | 3004153171 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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