Device recall
Z-1397-2010: SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA…
FDA device recall · Class II · Mindray DS USA, Inc., dba Datascope Patient Monitoring
Key facts
| Recall number (Z-number) | Z-1397-2010 |
|---|---|
| Recall event | 54175 |
| Product | SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains… |
| Product code | DQA |
| Recalling firm | Mindray DS USA, Inc., dba Datascope Patient Monitoring |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2011 |
| 510(k) numbers | K072235 |
| FEI number | 2221819 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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