FDA recall Z-1829-2020

Baxter Healthcare Corporation · Class II · device

Product

Prismaflex System, Prismaflex Control Unit

Reason for recall

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Distribution

Distribution in US, Puerto Rico

Key facts

Status
Terminated
Initiation date
2020-02-06
Report date
2020-05-06
Termination date
2021-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1829-2020