Cardinal Health 200, LLC: Medical Device Recall in 2021 - (Recall #: Z-1347-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Enteral Infusion Pump

Product Classification:

Class II

Date Initiated: January 19, 2021

Date Posted: April 14, 2021

Recall Number: Z-1347-2021

Event ID: 87281

Reason for Recall:

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

Status: Completed

Product Quantity: 146,944,334 units

Code Information:

Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated