Device recall
Z-1713-2009: SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm)…
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-1713-2009 |
|---|---|
| Recall event | 52457 |
| Product | SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO, Rx only. Intended for use for the introduction of catheters into a… |
| Product code | DQX |
| Recalling firm | St. Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2012 |
| 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