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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity Pump

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 Class 2 Device Recall Infinity Pump see related information
Date Posted November 15, 2012
Recall Status1 Terminated on January 30, 2014
Recall Number Z-0294-2013
Recall Event ID 63660
510(K)Number K031199 
Product Classification Pump, infusion, enteral - Product Code LZH
Product EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications.

The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.
Code Information 8174, 511038176, 511038177, 511038178, 511038179, 511038180, 511038181, 511038182, 511038183, 511038184, 511038185, 511038186, 511038187, 511038188, 511038189, 511038190, 511038191, 511038192, 511038193, 511038194, 511038195, 511038196, 511038197, 511038198, 511038199, 511038200, 511038201, 511038202, 511038203, 511038204, 511038205, 511038206, 511038207, 511038208, 511038209, 511038210, 511038211, 511038212, 511038213, 511038214, 511038215, 511038216, 511038217, 511038218, 511038219, 511038220, 511038221, 511038222, 511038223, 511038224, 511038225, 511038226, 511038227, 511038228, 511038229, 511038230, 511038231, 511038232, 511038233, 511038234, 511038235, 511038236, 511038237, 511038238, 511038239, 511038240, 511038241, 511038242, 511038243, 511038244, 511038245, 511038246, 511038247, 511038248, 511038249, 511038250, 511038251, 511038252, 511038254, 511038255, 511038256, 511038257, 511038258, 511038259, 511038260, 511038261, 511038262, 511038263, 511038264, 511038265, 511038266, 511038267, 511038268, 511038269, 511038270, 511038271, 511038272, 511038273, 511038274, 511038275, 511038276, 511038277, 511038278, 511038279, 511038280, 511038282, 511038283, 511038284, 511038285, 511038286, 511038287, 511038288, 511038289, 511038290, 511038291, 511038292, 511038293, 511038294, 511038295, 511038296, 511038297, 511038298, 511038299, 511038300, 511038301, 511038302, 511038303, 511038304, 511038305, 511038306, 511038307, 511038308, 511038309, 511038310, 511038311, 511038312, 511038313, 511038314, 511038315, 511038316, 511038317, 511038318, 511038319, 511038320, 511038321, 511038322, 511038323, 511038324, 511038325, 511038326, 511038327, 511038328, 511038329, 511038330, 511038331, 511038332, 511038333, 511038334, 511038335, 511038336, 511038337, 511038338, 511038339, 511038340, 511038341, 511038342, 511038343, 511038344, 511038345, 511038346, 511054001, 511054002, 511054003, 511054004, 511054005, 511054006, 511054007, 511054008, 511054009, 511054010, 511054011, 511054012, 511054013, 511054014, 511054015, 511054016, 511054017, 511054018, 511054019, 511054020, 511054021, 511054022, 511054023, 511054024, 511054025, 511054026, 511054027, 511054028, 511054029, 511054030, 511054031, 511054032, 511054033, 511054034, 511054035, 511054036, 511054037, 511054038, 511054039, 511054040, 511055001, 511055002, 511055003, 511055004, 511055005, 511055006, 511055007, 511055008, 511055009, 511055010, 511055011, 511055012, 511055013, 511055014, 511055015, 511055016, 511055017, 511055018, 511055019, 511055020, 511055021, 511055022, 511055023, 511055024, 511055025, 511055026, 511055027, 511055028, 511055029, 511055030, 511055031, 511055032, 511055033, 511055034, 511055035, 511055036, 511055037, 511055038, 511055039, 511055040, 511055041, 511055042, 511055043, 511055044, 511055045, 511055046, 511055047, 511055048, 511055049, 511055050, 511055051, 511055052, 511055053, 511055054, 511055056, 511055057, 511055058, 511055059, 511055060, 511055062, 511055063, 511055064, 511055065, 511055066, 511055067, 511055068, 511055069, 511055070, 511055071, 511055072, 511055073, 511055074, 511055075, 511055076, 511055077, 511055078, 511055079, 511055080, 511055081, 511063001, 511063002, 511063003, 511063004, 511063005, 511063006, 511063007, 511063008, 511063009, 511063010, 511063011, 511063012, 511063013, 511063014, 511063015, 511063016, 511063017, 511063018, 511063019, 511063020, 511063021, 511063022, 511063023, 511063024, 511063025, 511063026, 511063027, 511063028, 511063029, 511063030, 511063031, 511063032, 511063033, 511063034, 511063035, 511063036, 511063037, 511063038, 511063039, 511063040, 511063041, 511063042, 511063043, 511063044, 511063045, 511063046, 511063047, 511063048, 511063049, 511063050, 511063051, 511063052, 511063053, 511063054, 511063055, 511063056, 511063057, 511063058, 511063059, 511063060, 511063061, 511063062, 511063063, 511063064, 511063065, 511063066, 511063067, 511063068, 511063069, 511063070, 511063071, 511063072, 511063073, 511063074, 511063075, 5
Recalling Firm/
Manufacturer
MOOG Medical Devices Group
4314 Zevex Park Ln
Salt Lake City UT 84123-7881
For Additional Information Contact
801-264-1001 Ext. 264
Manufacturer Reason
for Recall
MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.
FDA Determined
Cause 2
Component design/selection
Action MOOG Medical Devices Group sent a Urgent Medical Device Recall letter dated November 8, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to contact Moog Medical Devices Group to discuss the process for product replacement at 1-800-970-2337, prompt #7. See Attachment A to determine if you have a serial number that is related to a suspect pump. Determine the number of affected pumps. Notify all of your affected customers of the recall and the protocol for getting a replacement pump. Provide serial numbers, number of product(s) to be returned and a shipping address for replacement product. Execute the pump replacement process discussed in the conversation with Moog Customer Advocacy. Package and return product via shipping label.
Quantity in Commerce 8,736
Distribution Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZH and Original Applicant = ZEVEX INTL., INC.
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