B. Braun Medical, Inc. Recall 88198
Description: Infusomat Space Volumetric Pump Administration Set, Product Code 490100
B. Braun Medical, Inc. Recall 88198 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2137-2021 |
| Event ID | 88198 |
| Event Description | Infusomat Space Volumetric Pump Administration Set, Product Code 490100 |
| Product Type | Devices |
| Distribution | Affected products were distributed to the following US states: CA, MI, OR, and UT. |
| Quantity | 36,144 units |
| Recall Reason | There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump. |
| Device Classification | 20210804 |
| Device Code Info | Lot Number: 0061761278 |
| Center Classification Date | 20210723 |
| Recall Initiation Date | 20210625 |
| Recalling Firm | B. Braun Medical, Inc. |
| Initial Notification | Letter |
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