Device recall
Z-2180-2010: St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length,.035"…
FDA device recall · Class I · St. Jude Medical Cardiovascular Division
Key facts
| Recall number (Z-number) | Z-2180-2010 |
|---|---|
| Recall event | 56222 |
| Product | St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549. |
| Product code | DYB |
| Recalling firm | St. Jude Medical Cardiovascular Division |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 27, 2011 |
| 510(k) numbers | K091137, K092575, K093130 |
| FEI number | 2182269 |
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