Device recall
Z-2333-2008: Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108…
FDA device recall · Class II · Oscor, Inc.
Key facts
| Recall number (Z-number) | Z-2333-2008 |
|---|---|
| Recall event | 48678 |
| Product | Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor… |
| Product code | DTB |
| Recalling firm | Oscor, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 14, 2008 |
| 510(k) numbers | K010787, K040569, K041809, K872971 |
| FEI number | 1035166 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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