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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity Enteral Feeding infusion pump

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  Class 2 Device Recall Infinity Enteral Feeding infusion pump see related information
Date Initiated by Firm October 12, 2012
Date Posting Updated January 31, 2013
Recall Status1 Terminated 3 on April 10, 2014
Recall Number Z-0764-2013
Recall Event ID 63485
510(K)Number K031199  
Product Classification Pump, infusion, enteral - Product Code LZH
Product Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual

Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
Code Information 510190031, 510190040, 510190039, 510190038, 510190037, 510190036, 510190035, 510190076, 510190075, 510190077, 510190046, 510190045, 510190044, 510190043, 510190042, 510190041, 510190032, 510190033, 510190047, 510190048, 510190034, 510190074, 510190073, 510190072, 510190071, 510190070, 510190069, 510190068, 510190067, 510190066, 510190065, 510190064, 510190063, 510190062, 510190061, 510190060, 510190059, 510190058, 510190057, 510190056, 510190055, 510190054, 510190053, 510190052, 510190051, 510190049, 510190078, 510190079, 510190080, 510190081, 510190082, 510190088, 510190086, 510190085, 510190084, 510190083, 510190089, 510190090, 510190091, 510190094, 510190095, 510190092, 510190093, 510190102, 510190101, 510190100, 510190099, 510190098, 510190097, 510190096, 510190103, 510190104, 510190105, 510190106, 510190107, 510190108, 510190109, 510190110, 510190111, 510190112, 510190113, 510190114, 510190115, 510190116, 510190118, 510190117, 510190121, 510190122, 510190119, 510190120, 510190126, 510190127, 510190128, 510190129, 510190130, 510190131, 510190132, 510190133, 510190125, 510190124, 510190123, 510190134, 510190136, 510190135, 510190139, 510190140, 510190141, 510193001, 510193003, 510193004, 510193005, 510193006, 510193007, 510193008, 510190137, 510190138, 510193009, 510193010, 510193011, 510193012, 510193013, 510193018, 510193017, 510193016, 510193015, 510193014, 510193032, 510193033, 510193034, 510193035, 510193036, 510193037, 510193038, 510193039, 510193040, 510193041, 510193042, 510193043, 510193044, 510193045, 510193046, 510193047, 510193048, 510193049, 510193050, 510193051, 510193021, 510193020, 510193019, 510193026, 510193027, 510193028, 510193029, 510193030, 510193031, 510193023, 510193024, 510193025, 510193022, 510193052, 510193071, 510193072, 510193073, 510193074, 510193075, 510193076, 510193077, 510193078, 510193079, 510193080, 510193082, 510193081, 510193056, 510193055, 510193054, 510193053, 510193069, 510193070, 510193068, 510193067, 510193066, 510193065, 510193064, 510193063, 510193062, 510193061, 510193060, 510193059, 510193058, 510193057, 510193122, 510193121, 510193120, 510193119, 510193118, 510193117, 510193116, 510193115, 510193114, 510193113, 510193112, 510193111, 510193110, 510193109, 510193108, 510193107, 510193106, 510193105, 510193103, 510193102, 510193101, 510193100, 510193099, 510193098, 510193097, 510193090, 510193089, 510193088, 510193087, 510193086, 510193085, 510193084, 510193083, 510193123, 510193093, 510193094, 510193095, 510193096, 510193092, 510193091, 510193141, 510193142, 510193143, 510193144, 510193145, 510193146, 510193147, 510193148, 510193149, 510193150, 510193151, 510193152, 510193153, 510193154, 510193155, 510193156, 510193157, 510193158, 510193159, 510193160, 510193161, 510193140, 510193139, 510193136, 510193137, 510193138, 510193135, 510193133, 510193132, 510193131, 510193130, 510193129, 510193128, 510193127, 510193126, 510193125, 510193124, 510193134, 510193176, 510193177, 510193163, 510193183, 510193182, 510193181, 510193179, 510193178, 510193162, 510193164, 510193165, 510193166, 510193167, 510193168, 510193169, 510193170, 510193171, 510193172, 510193173, 510193174, 510193175, 510193184, 510194003, 510194002, 510194001, 510194039, 510194040, 510194041, 510194042, 510194038, 510194037, 510194036, 510194035, 510194034, 510194033, 510194032, 510194044, 510194043, 510194031, 510194030, 510194029, 510194028, 510194027, 510194026, 510194025, 510194015, 510194016, 510194017, 510194018, 510194019, 510194020, 510194021, 510194022, 510194023, 510194024, 510194004, 510194005, 510194006, 510194007, 510194008, 510194009, 510194010, 510194011, 510194012, 510194013, 510194014, 510194064, 510194065, 510194066, 510194067, 510194068, 510194069, 510194070, 510194071, 510194072, 510194073, 510194074, 510194075, 510194076, 510194077, 510194078, 510194079, 510218001, 510218016, 510218015, 510218014, 510194081, 510194080, 510194048, 510194047, 510194046, 510194045, 510218002, 510218003, 510218004, 5102180
Recalling Firm/
Manufacturer
MOOG Medical Devices Group
4314 Zevex Park Ln
Salt Lake City UT 84123-7881
For Additional Information Contact Holly Imes
801-264-1001 Ext. 230
Manufacturer Reason
for Recall
The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
FDA Determined
Cause 2
Nonconforming Material/Component
Action An Urgent Field Safety Notice was sent to all original consignees by certified mail beginning on Monday, October 15, 2012. Consignees were provided with an Addendum to the Operator's Manual as part of the Notice. Consignees were instructed to assure pump users are aware of the information in the addendum and to store the addendum with the Operator's Manual. Consignees were also requested to complete and return a Medical Device Recall reply form to the firm. For additional information or clarification, consignees are to contact Holly Imes, Manager, Regulatory Affairs at 801-264-1001, ext. 230 or via email at: himesstark@moog.com.
Quantity in Commerce 92,488 units
Distribution Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
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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