Device recall
Z-1992-2012: Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly…
FDA device recall · Class I · B. Braun Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1992-2012 |
|---|---|
| Recall event | 62115 |
| Product | Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood… |
| Product code | FRN |
| Recalling firm | B. Braun Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 3, 2014 |
| 510(k) numbers | K062700, K083689 |
| FEI number | 2523676 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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