FDA Device

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.

Hazard

Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.

What You Should Do

Remedy

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.

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Products

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 nut
Brand
Zevex International, Inc.
UPC
Serial numbers in range: 506297001 - 508290050

Units Affected

32,545

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