Device recall
Z-2228-2009: St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM…
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-2228-2009 |
|---|---|
| Recall event | 53121 |
| Product | St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. Used for the introduction of catheters into a vessel. |
| Product code | DQX |
| Recalling firm | St. Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K791129 |
| 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