Device recall
Z-0197-2024: Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic…
FDA device recall · Class II · Quest Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0197-2024 |
|---|---|
| Recall event | 93116 |
| Product | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. |
| Product code | FPA |
| Recalling firm | Quest Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K151079 |
| FEI number | 3001665800 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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