FDAClass IIApril 14, 2021

Enteral Infusion Pump recall

Enteral Infusion Pump

Why was Enteral Infusion Pump recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Enteral Infusion Pump
Recalling firm
Cardinal Health 200, LLC
Quantity
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
Recall date
April 14, 2021
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls