Device recall
Z-0097-2019: Codan Filter (Codan catalog number BC 693) used with Medrad Patient…
FDA device recall · Class II · Bayer Medical Care, Inc.
Key facts
| Recall number (Z-number) | Z-0097-2019 |
|---|---|
| Recall event | 80945 |
| Product | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets |
| Product code | FPA |
| Recalling firm | Bayer Medical Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2019 |
| 510(k) numbers | K830755 |
| FEI number | 2520313 |
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