RecallRadar

FDA Device recall Z-2489-2019

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

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

AgencyFDA Device
Recall numberZ-2489-2019
ClassificationClass I
Statusterminated
Initiated2019-05-01
Published2019-10-02
Last updated2026-09-13 11:55 UTC
CompanyB Braun Medical
DistributionTX

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_infoLot 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.