Device recall
Z-2582-2010: Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament…
FDA device recall · Class II · C P Medical
Key facts
| Recall number (Z-number) | Z-2582-2010 |
|---|---|
| Recall event | 49599 |
| Product | Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 EXP 2009-11...4/0 M397A...Mono-Dox CUTTING NFS-2 NEEDLE...Manufactured by: CP Medical, Portland, OR… |
| Product code | NEW |
| Recalling firm | C P Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2010 |
| 510(k) numbers | K013274 |
| FEI number | 3002609049 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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