Enforcement Report - Week of February 6, 2013
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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 |
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