Use caution Medical device recall · FDA · Published January 19, 2021

Cardinal Health Enteral Infusion Pump Recall: Air in Tubing During Setup

Cardinal Health recalls specific enteral infusion pumps due to potential air entering tubing during setup, which could cause feeding issues. Affected models include 612054, 613650, and others listed in the recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1347-2021Medical device Cardinal Health ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337

✎ GovInfoNow plain-language explainer

Cardinal Health is recalling certain enteral infusion pumps because air might enter the tubing during setup. This could lead to improper feeding and health risks for patients using the pumps. Read more at govinfonow.com/recall/63365-cardinal-health-enteral-infusion-pump-recall-air-in-tubing-during.

Source Summary by GovInfoNow · govinfonow.com/recall/63365-cardinal-health-enteral-infusion-pump-recall-air-in-tubing-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1347-2021

Cite this page

“Cardinal Health Enteral Infusion Pump Recall: Air in Tubing During Setup.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63365-cardinal-health-enteral-infusion-pump-recall-air-in-tubing-during. Based on FDA recall #Z-1347-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1347-2021%22&limit=1).

Cardinal Health 200, LLC recalled Enteral Infusion Pumps on Jan. 19, 2021, according to the FDA. The devices pose a hazard because air may appear in the enteral feed pumping set tubing during setup.

How to tell if you have it

Brand: Cardinal Health
Product: Enteral Infusion Pump
Catalog Numbers: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150
Units: 146,944,334

The hazard

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

Context

GovInfoNow's records show Cardinal Health 200, LLC has 59 other recalls on record since 2017-06-27. Other recent recalls of similar products include ICU Medical Plum Duo Infusion Pump Recall (2025-12-15), B Braun Medical: Infusomat pumps may cause medication backflow in IV systems (2025-10-29), and ICU Medical Plum Solo IV Pump Recall (2025-12-15).

How to tell if you have this one

Check the pump's catalog number on the label. Affected models include 612054, 613650, 614650, and others listed in the recall notice.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Pump Model
Look for the catalog number on the pump's label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jan 19, 2021Firm started the recall
Apr 2, 2021FDA classified it Class II
Apr 14, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What models are affected by this recall?

Affected models include 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150.

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Link to this recall

<a href="https://govinfonow.com/recall/63365-cardinal-health-enteral-infusion-pump-recall-air-in-tubing-during">Cardinal Health Enteral Infusion Pump Recall: Air in Tubing During Setup (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1347-2021 (January 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1347-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.