Device recall
Z-2285-2018: Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product…
FDA device recall · Class II · B. Braun Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2285-2018 |
|---|---|
| Recall event | 80142 |
| Product | Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver… |
| Product code | FPA |
| Recalling firm | B. Braun Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2019 |
| 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