Z-2489-2019Class I

B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

Name: Z-2489-2019 B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Creator: B. Braun Medical, Inc.
Published: 2019-05-01
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2019-05-01 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 on 2019-05-01. FDA classified it as Class I and gives the reason as "Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2489-2019
Classification: Class I
Status: Terminated
Initiated: 2019-05-01
Posted: 2019-09-23
Terminated: 2020-07-13
Recalling firm: B Braun Medical Inc
Product: B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Product code: FPA Set, Administration, Intravascular
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).
FDA root cause: Other
Action: Urgent Medical Device - Recall Notification letters dated 4/30/19 were sent to customers.
Quantity in commerce: 2580
Distribution: Distribution to US state of TX, and Canada.
Product codes and lots: Lot Number 0061641410

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2489-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2489-2019	Class I	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-23

Product code FPA

K142036Class IIInfusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. / cleared 2014-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)