FDA Device recall Z-2489-2019
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
- FDA Device
- Class I
- terminated
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class I recall of B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 by B Braun Medical, citing potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2489-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-05-01 |
| Published | 2019-10-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | B Braun Medical |
| Distribution | TX |
Product
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Reason
Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
Identifiers
| code_info | Lot Number 0061641410 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2489-2019%22
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