Device recall
Z-3327-2026: Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat…
FDA device recall · Class II · SPECTRUM MEDICAL SRL
Key facts
| Recall number (Z-number) | Z-3327-2026 |
|---|---|
| Recall event | 99462 |
| Product | Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood… |
| Product code | DTR |
| Recalling firm | SPECTRUM MEDICAL SRL |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K220110, K223879 |
| FEI number | 3016746283 |
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