Device recall
Z-1038-2012: Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO…
FDA device recall · Class II · European Custom Manufacturing B.V.
Key facts
| Recall number (Z-number) | Z-1038-2012 |
|---|---|
| Recall event | 60942 |
| Product | Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device… |
| Product code | LDF |
| Recalling firm | European Custom Manufacturing B.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2012 |
| 510(k) numbers | K033858 |
| FEI number | 2242056 |
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