B — Class I medical device recall Z-2489-2019
Terminated recall by B. Braun Medical, Inc., reported 2019-10-02, distributed in TX. Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the t
| Recall number | Z-2489-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2019-05-01 |
| Classified | 2019-09-23 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2020-07-13 |
| Distributed | TX |
| Countries outside the US | CA |
| Quantity | 2,580 |
| Reason classes | packaging |
| Lot numbers | 0061641410 |
| Model numbers | 363032 |
Product
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Reason for recall
Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2489-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.