Device recall
Z-0391-2019: TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight…
FDA device recall · Class I · Oscor, Inc.
Key facts
| Recall number (Z-number) | Z-0391-2019 |
|---|---|
| Recall event | 80984 |
| Product | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an… |
| Product code | LDF |
| Recalling firm | Oscor, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 4, 2022 |
| 510(k) numbers | K861403, K884866 |
| FEI number | 1035166 |
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