Device recall
Z-1158-2007: Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar…
FDA device recall · Class II · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-1158-2007 |
|---|---|
| Recall event | 38005 |
| Product | Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device. Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004-0011 |
| Product code | GEI |
| Recalling firm | Datascope Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2008 |
| 510(k) numbers | K003587 |
| FEI number | 1000222374 |
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