Device recall
Z-0331-2017: HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-0331-2017 |
|---|---|
| Recall event | 75372 |
| Product | HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external… |
| Product code | DQO |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 20, 2020 |
| 510(k) numbers | K895268 |
| FEI number | 3015859709 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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