Z-2112-2009

EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake...

Name: Z-2112-2009 EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake...
Creator: Zevex International, Inc.
Published: 2008-12-18
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2008-12-18 / Terminated / root cause: software

FDA source

Zevex International, Inc. began a recall of EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. A rotary peristaltic pump designed to... on 2008-12-18. The reason FDA records is "Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2112-2009
Status: Terminated
Initiated: 2008-12-18
Posted: 2009-09-21
Terminated: 2011-10-27
Recalling firm: Zevex, Inc.
Product: EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. A rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.
Product code: LZH Pump, Infusion, Enteral
Reason for recall: Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: All of Zevex' customers and distributors were notified by an Urgent Medical Device Correction letter, dated 12/18/2008. The letters explained the issue, the patient impact, and what necessary actions should be taken. Customers were instructed to contact Zevex to schedule the upgrade of their installed base of pumps at 800-970-2337 or [email protected]. Distributors were to contact their customers and notify them of the letter.
Quantity in commerce: 32,545
Distribution: Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.
Product codes and lots: Serial numbers in range: 506297001 - 508290050

Product code LZH

K031199Class IIEnteralite Infinity Enteral Feeding PumpZevex Intl., Inc. / cleared 2003-07-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)