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U.S. Department of Health and Human Services

Class 2 Device Recall EnteraLite Infinity Enteral Feeding Pump

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  Class 2 Device Recall EnteraLite Infinity Enteral Feeding Pump see related information
Date Initiated by Firm December 18, 2008
Date Posted September 21, 2009
Recall Status1 Terminated 3 on October 27, 2011
Recall Number Z-2112-2009
Recall Event ID 50687
510(K)Number K031199  
Product Classification Enteral Infusion Pump - Product Code LZH
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.
Code Information Serial numbers in range: 506297001 - 508290050
Recalling Firm/
Manufacturer		 Zevex International, Inc.
4314 Zevex Park Ln
Salt Lake City UT 84123
For Additional Information Contact
801-264-1001
Manufacturer Reason
for Recall		 Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
FDA Determined
Cause 2		 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 in Commerce 32,545
Distribution Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZH and Original Applicant = ZEVEX INTL., INC.
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