Device recall
Z-0936-2023: HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER…
FDA device recall · Class II · Stradis Healthcare
Key facts
| Recall number (Z-number) | Z-0936-2023 |
|---|---|
| Recall event | 91350 |
| Product | HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. |
| Product code | KPE |
| Recalling firm | Stradis Healthcare |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190328 |
| FEI number | 1450943 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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