Device recall
Z-1769-2017: Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number…
FDA device recall · Class II · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-1769-2017 |
|---|---|
| Recall event | 76518 |
| Product | Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open… |
| Product code | DWE |
| Recalling firm | Datascope Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2019 |
| 510(k) numbers | K080592 |
| FEI number | 1000222374 |
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