Device recall
Z-1776-2018: Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018…
FDA device recall · Class II · Transonic Systems Inc
Key facts
| Recall number (Z-number) | Z-1776-2018 |
|---|---|
| Recall event | 79750 |
| Product | Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s… |
| Product code | PEH |
| Recalling firm | Transonic Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2019 |
| 510(k) numbers | K021571 |
| FEI number | 1319030 |
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