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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description 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.
Recall Number Z-0764-2013
Classification Class II
Code Info 003, 509350004, 509350005, 509350006, 509350007, 509350008, 509350009, 509350010, 509350011, 509350012, 509350013, 509350014, 509350015, 509350016, 509350017, 509350018, 509350019, 509350020, 509350021, 509350022, 509350023, 509350024, 509350025, 509350026, 509350027, 509350028, 509350029, 509350030, 509350031, 509350032, 509350033, 509350034, 509350035, 509350036, 509350037, 509350038, 509350039, 509350040, 509350041, 509350042, 509350043, 509350044, 509350045, 509350046, 509350047, 509350048, 509350049, 509350050, 509350051, 509350052, 509350053, 509350054, 509350055, 509350056, 509350057, 509350058, 509350059, 509350060, 509350061, 509350062, 509350063, 509350064, 509350065, 509350066, 509350067, 509350068, 509350069, 509350070, 509350071, 509350072, 509350073, 509350074, 509350075, 509350076, 509350077, 509350078, 509350079, 509350080, 509350081, 509350082, 509350083, 509350084, 509350085, 509350086, 509350087, 509350088, 509350089, 509350090, 509350091, 509350092, 509350093, 509350094, 509350095, 509350096, 509350097, 509350098, 509350099, 509350100, 509350101, 509350102, 509350103, 509350104, 509350105, 509345014, 509345015, 509345016, 509345017, 509345018, 509345019, 509345020, 509345021, 509345005, 509345006, 509345007, 509345008, 509345009, 509351011, 509351012, 509351013, 509351014, 509351015, 509351016, 509351017, 509351018, 509351019, 509351020, 509351021, 509351022, 509351023, 509351024, 509351025, 509351026, 509351027, 509351028, 509351029, 509351030, 509351031, 509351032, 509351033, 509351034, 509351035, 509351038, 509351037, 509351003, 509351004, 509351005, 509351006, 509351007, 509351008, 509351009, 509351010, 509351036, 509351039, 509351040, 509351041, 509351042, 509351043, 509351049, 509351050, 509351051, 509351052, 509351053, 509351054, 509351055, 509351056, 509351057, 509351058, 509351059, 509351060, 509351061, 509351062, 509351063, 509351064, 509351065, 509351066, 509351067, 509351068, 509351069, 509351070, 509351071, 509351072, 509351073, 509351048, 509351047, 509351046, 509351045, 509351044, 509351103, 509351102, 509351101, 509351100, 509351099, 509351098, 509351097, 509351096, 509351095, 509351094, 509351093, 509351092, 509351091, 509351090, 509351089, 509351088, 509351087, 509351086, 509351085, 509351084, 509351083, 509351082, 509351081, 509351080, 509351079, 509351078, 509351077, 509351076, 509351075, 509351074, 509351112, 509351127, 509351128, 509351129, 509351130, 509351131, 509351132, 509351113, 509351114, 509351115, 509351116, 509351117, 509351118, 509351119, 509351120, 509351121, 509351122, 509351123, 509351124, 509351125, 509351126, 509351133, 509351134, 509351135, 509351136, 509351137, 509351138, 509351106, 509351105, 509351107, 509351108, 509351109, 509351111, 509351110, 509351104, 509357071, 509357070, 509357069, 509357068, 509357067, 509357077, 509357076, 509357075, 509357074, 509357073, 509357072, 509357066, 509357065, 509357064, 509357063, 509357062, 509351154, 509357030, 509351156, 509351157, 509357031, 509351158, 509357055, 509351159, 509351160, 509351153, 509357034, 509357033, 509351152, 509351151, 509357056, 509351150, 509351149, 509351161, 509357035, 509357036, 509351148, 509357032, 509351146, 509351145, 509351144, 509351143, 509357037, 509357038, 509357039, 509351162, 509351163, 509351164, 509357040, 509351142, 509351141, 509351140, 509351139, 509351165, 509357041, 509351166, 509351167, 509357042, 509357043, 509357044, 509357045, 509357046, 509357047, 509351168, 509351155, 509357049, 509351170, 509357050, 509357051, 509357052, 509357053, 509351171, 509351172, 509357001, 509357002, 509357003, 509357004, 509357005, 509357006, 509357007, 509357008, 509357009, 509357010, 509357057, 509357011, 509357012, 509357013, 509357054, 509357014, 509357061, 509357015, 509357016, 509357017, 509357018, 509357019, 509357020, 509357021, 509357022, 509357058, 509357023, 509357024, 509357025, 509357026, 509357027, 509357028, 509357029, 509357059, 509357060, 509351169, 509357048, 509351147, 509357078, 50
Product Distributed Qty 92,488 units
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.

Event Detail

Event Id 63485
Product Type Devices
Status Ongoing
Recalling Firm MOOG Medical Devices Group
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
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