Class I — B. Braun Medical, Inc.
| Recalling firm | B. BRAUN MEDICAL INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| 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). |
| Product | B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 |
| Quantity | 2580 |
| Distribution | Distribution to US state of TX, and Canada. |
| Initiated | 2019-05-01 |
| Classified | 2019-09-23 |
| Terminated | 2020-07-13 |
| Recall number | Z-2489-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — B. Braun Medical, Inc. (Z-2489-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82966/
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