FDA recall Z-2489-2019

B. Braun Medical, Inc. · Class I · device

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).

Distribution

Distribution to US state of TX, and Canada.

Key facts

Status
Terminated
Initiation date
2019-05-01
Report date
2019-10-02
Termination date
2020-07-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2489-2019