Device recall
Z-0483-2021: Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe…
FDA device recall · Class II · Bayer Medical Care, Inc.
Key facts
| Recall number (Z-number) | Z-0483-2021 |
|---|---|
| Recall event | 86619 |
| Product | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL… |
| Product code | DXT |
| Recalling firm | Bayer Medical Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 19, 2021 |
| 510(k) numbers | K192370 |
| FEI number | 2520313 |
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