Device recall
Z-0910-2023: Source Administration Set (SAS) used with the Medrad Intego PET Infusion System…
FDA device recall · Class II · Bayer Medical Care, Inc.
Key facts
| Recall number (Z-number) | Z-0910-2023 |
|---|---|
| Recall event | 91273 |
| Product | Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing… |
| Product code | FRN |
| Recalling firm | Bayer Medical Care, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K100798 |
| FEI number | 2520313 |
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