Z-1347-2021Class II

Enteral Infusion Pump

Name: Z-1347-2021 Enteral Infusion Pump
Creator: Cardinal Health 200, LLC
Published: 2021-01-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-01-19 / Completed / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Enteral Infusion Pump on 2021-01-19. FDA classified it as Class II and gives the reason as "The potential for air appearing in the enteral feed pumping set tubing during set-up". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1347-2021
Classification: Class II
Status: Completed
Initiated: 2021-01-19
Posted: 2021-04-02
Recalling firm: Medtronic, Inc.
Product: Enteral Infusion Pump
Product code: LZH Pump, Infusion, Enteral
Reason for recall: The potential for air appearing in the enteral feed pumping set tubing during set-up.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 03/01/2021, Cardinal Health issued an Urgent Medical Device Correction notice to customers via letter to the potential of air entering the feed set tubing of enteral fusion pumps with the specified product codes
Quantity in commerce: 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
Product codes and lots: Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1347-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1347-2021	Class II	Completed	Voluntary: Firm initiated	2021-04-14	2021-04-02

Product code LZH

K040196Class IIKendall Epump Enteral Feeding Pump and Enteral Feeding SetsTyco Healthcare/Kendall / cleared 2004-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)