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.
FDA Recall Z-2112-2009 · Posted 2009-09-21
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Recalling FirmZevex International, Inc.
Recall StatusTerminated
Product CodeLZH
Date Initiated2008-12-18
Date Terminated2011-10-27
Product Quantity32,545
Reason for Recall
Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
Firm 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.
Root Cause
Software design (manufacturing process)
Distribution Pattern
Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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