FDA recall Z-0938-2021

Product

ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

Reason for recall

CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2020-12-18

Report date

2021-02-10

Termination date

2021-05-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2021