Device recall
Z-1584-2016: Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage…
FDA device recall · Class II · RESEARCH INSTRUMENTS LTD - SITE B
Key facts
| Recall number (Z-number) | Z-1584-2016 |
|---|---|
| Recall event | 73581 |
| Product | Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500… |
| Product code | MQJ |
| Recalling firm | RESEARCH INSTRUMENTS LTD - SITE B |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2021 |
| 510(k) numbers | K003142 |
| FEI number | 3003751666 |
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