Device recall
Z-0604-2026: ADDitIV utilized in gravity IV administration sets and pump administration sets…
FDA device recall · Class II · B Braun Medical Inc
Key facts
| Recall number (Z-number) | Z-0604-2026 |
|---|---|
| Recall event | 97816 |
| Product | ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. V1782F UNIV IV SET W/0.2 MICRON FILTER; Catalog Number: 352447. |
| Product code | FPA |
| Recalling firm | B Braun Medical Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K790062 |
| FEI number | 2521402 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 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