PlainRecalls
FDA Devices Moderate Class II Completed

Enteral Infusion Pump

Reported: April 14, 2021 Initiated: January 19, 2021 #Z-1347-2021

Product Description

Enteral Infusion Pump

Reason for Recall

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

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
146,944,334 units
Distribution
Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
Enteral Infusion Pump. Recalled by Cardinal Health 200, LLC. Units affected: 146,944,334 units.
Why was this product recalled?
The potential for air appearing in the enteral feed pumping set tubing during set-up.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1347-2021.