FDA recall Z-2137-2021

Product

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Reason for recall

There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

Distribution

Affected products were distributed to the following US states: CA, MI, OR, and UT.

Key facts

Status

Terminated

Initiation date

2021-06-25

Report date

2021-08-04

Termination date

2023-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2137-2021