FDA Device recall Z-2137-2021
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
- FDA Device
- Class II
- terminated
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of Infusomat Space Volumetric Pump Administration Set, Product Code 490100 by B Braun Medical, citing 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 clos….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2137-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-25 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | CA, MI, OR, UT |
Product
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
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.
Identifiers
| code_info | Lot Number: 0061761278 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2137-2021%22
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