Device recall
Z-0091-2023: Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per…
FDA device recall · Class II · B. Braun Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0091-2023 |
|---|---|
| Recall event | 90850 |
| Product | Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. |
| Product code | FPA |
| Recalling firm | B. Braun Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K083723, K942988, K954123 |
| FEI number | 2523676 |
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