FDA recall Z-1347-2021

Product

Enteral Infusion Pump

Reason for recall

The potential for air appearing in the enteral feed pumping set tubing during set-up.

Distribution

Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey

Key facts

Status

Completed

Initiation date

2021-01-19

Report date

2021-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1347-2021