Device recall
Z-2548-2021: 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the…
FDA device recall · Class II · B. Braun Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2548-2021 |
|---|---|
| Recall event | 88531 |
| Product | 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216 |
| Product code | FPA |
| Recalling firm | B. Braun Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2024 |
| 510(k) numbers | K083723, K922637 |
| FEI number | 2523676 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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