FDA recall Z-2055-2019

InfuTronix LLC · Class II · device

Product

Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

Reason for recall

Potential for tube leakage

Distribution

US distribution in the state of MA

Key facts

Status
Terminated
Initiation date
2019-05-28
Report date
2019-07-31
Termination date
2020-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Natick, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2055-2019