• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

  • Print
  • Share
  • E-mail
-

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).

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II 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. 92,488 units Z-0764-2013
-
-