Device recall
Z-0355-2024: Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set…
FDA device recall · Class I · B. Braun Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0355-2024 |
|---|---|
| Recall event | 93232 |
| Product | Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE… |
| Product code | FPA |
| Recalling firm | B. Braun Medical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K142036 |
| 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