FDA Medical Device Recalls (openFDA)
Zevex International, Inc.: 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.
- Recall number
- Z-2112-2009
- Recalling firm
- Zevex International, 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.
- Status
- Terminated
- Initiated
- 2008-12-18
- Posted
- 2009-09-21
- Terminated
- 2011-10-27
- Reason
- Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
- 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 sales@zevex.com. Distributors were to contact their customers and notify them of the letter.
- Quantity
- 32,545
- Distribution
- Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.
- Lot, serial or model codes
- Serial numbers in range: 506297001 - 508290050
- 510(k) numbers
- ["K031199"]
- PMA numbers
- not on file
- Product code
- LZH
- Firm FEI
- 1000117172
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28