Events

Retiro De Equipo (Recall) de Device Recall Medtronic Custom Packs and Total System Packs

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Perfusion Systems.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    31477
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0808-05
  • Fecha de inicio del evento
    2005-03-25
  • Fecha de publicación del evento
    2005-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37964
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
  • Causa
    Some warehouse inventory of custom pack product bags were found with ruptured seals. the seals were partially opened in the center of the bag's tyvek edge. since this bag is used to enclose and seal the custom pack assembly & had been sterilized, the ruptured seal breaches the sterility barrier for the package.
  • Acción
    US customers were sent certified letters beginning 03/25/05 identifying the situation, cautioning customers about the possibility of an open bag with loss of sterility and requested return of all product to Medtronic Perfusions Systems at 7611 Northland Blvd., Brooklyn Park, MN. Customers are also requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information.

Device

Device Recall Medtronic Custom Packs and Total System Packs
  • Modelo / Serial
    Catalog/custom Pack Number 0A39R17 with Lot no.''s 0411002937 and 0412002577 Catalog/Customer Pack Number 0A52R12 with Lot no. 0411005077; Catalog/Customer Pack Number 0E35R1 with Lot no. 0501004491; Catalog/Customer Pack Number 0M97R17 with Lot no. 0411005084; Catalog/Customer Pack Number 0M97R18 with Lot no. 0501002954; Catalog/Customer Pack Number 0M98R18 with Lot no. 0411003731; Catalog/Customer Pack Number 0M99R17 with Lot no. 0411003732; Catalog/Customer Pack Number 0N41R7 with Lot no.''s 0411000788, 0411006283, 0412002182 and 0501001313; Catalog/Customer Pack Number 0N70R14 with Lot no.''s 0411003196 and 0411003196; Catalog/Customer Pack Number 0R26R1 with Lot no. 0410004599; Catalog/Customer Pack Number 0Y50R8 with Lot no. 0501001053; Catalog/Customer Pack Number 0Z30R6 with Lot no. 0411000770; Catalog/Customer Pack Number 0Z99R1 with Lot no. 0502003204; Catalog/Customer Pack Number 1845R29 with Lot no. 0412005193; Catalog/Customer Pack Number 1A46R5 with Lot no. 0501003689; Catalog/Customer Pack Number 1A63R6 with Lot no. 0412002081; Catalog/Customer Pack Number 1B23R2 with Lot no. 0412001125; Catalog/Customer Pack Number 1B23R4 with Lot no. 0502002363; Catalog/Customer Pack Number 1B31R2 with Lot no.''s 0411002428, 0411003734, 0411006211, 0501001326, 0501002968 and 0501004492; Catalog/Customer Pack Number 1B37R4 with Lot no. 0501001675; Catalog/Customer Pack Number 1C33R1 with Lot no. 0411003738; Catalog/Customer Pack Number 1C44R4 with Lot no.''s 0410005787, 0412000449 and 0501004469; Catalog/Customer Pack Number 1C87R3 with Lot no. 0411005042; Catalog/Customer Pack Number 1D80R7 with Lot no. 0411003404; Catalog/Customer Pack Number 1D80R8 with Lot no. 0502000042; Catalog/Customer Pack Number 1E87R1 with Lot no. 0411002441; Catalog/Customer Pack Number 1E87R2 with Lot no. 04120030957; Catalog/Customer Pack Number 1E99R4 with Lot no. 0501002058; Catalog/Customer Pack Number 1F03R1 with Lot no. 0412000472; Catalog/Customer Pack Number 1F04R2 with Lot no''s. 0412003489 and 0501002849; Catalog/Customer Pack Number 1G06R11 with Lot no. 0412001595; Catalog/Customer Pack Number 1G37R3 with Lot no. 0411003209; Catalog/Customer Pack Number 1G69R7 with Lot no. 0412002553; Catalog/Customer Pack Number 1G75R1 with Lot no. 0412003470; Catalog/Customer Pack Number 1H24R6 with Lot no. 0412001207; Catalog/Customer Pack Number 1H50R5 with Lot no. 0411003411; Catalog/Customer Pack Number 1J01R with Lot no. 0501002510; Catalog/Customer Pack Number 1J29R1 with Lot no. 0501002848; Catalog/Customer Pack Number 1K09R3 with Lot no. 0412002172; Catalog/Customer Pack Number 1K72R4 with Lot no. 0502000853; Catalog/Customer Pack Number 1L77R7 with Lot no. 0411006056; Catalog/Customer Pack Number 1M68R2 with Lot no. 0412002559; Catalog/Customer Pack Number 1N25R5 with Lot no. 0502003198; Catalog/Customer Pack Number 1N77R6 with Lot no. 0501002933; Catalog/Customer Pack Number 1N93R1 with Lot no. 0502002615; Catalog/Customer Pack Number 1Q10R4 with Lot no. 0411006908; Catalog/Customer Pack Number 1Q28R1 with Lot no. 0412000476; Catalog/Customer Pack Number 1R13R2 with Lot no. 0411002155; Catalog/Customer Pack Number 1R14R2 with Lot no. 0501005938; Catalog/Customer Pack Number 1U84R3 with Lot no. 0411006923; Catalog/Customer Pack Number 2162R3 with Lot no.''s 0411005070 and 0412005207; Catalog/Customer Pack Number 2380R7 with Lot no. 0411006916; Catalog/Customer Pack Number 2567R34 with Lot no.''s 0412000978 and 0501003678; Catalog/Customer Pack Number 2841R32 with Lot no. 0411000393; Catalog/Customer Pack Number 2A96R with Lot no. 0411003443; Catalog/Customer Pack Number 2C88R2 with Lot no. 0412001122; Catalog/Customer Pack Number 2D86R8 with Lot no. 0411006913; Catalog/Customer Pack Number 2D93R6 with Lot no. 0411003730; Catalog/Customer Pack Number 2E74R9 with Lot no. 0411004495; Catalog/Customer Pack Number 2L74R4 with Lot no. 0411002893; Catalog/Customer Pack Number 2P77R3 with Lot no. 0411002443; Catalog/Customer Pack Number 2R17R1 with Lot no. 0412004981; Catalog/Customer Pack Number 2V38R2 with Lot no. 0411006212; Catalog/Customer Pack Number 2W79R1 with Lot no. 0411002930; Catalog/Customer Pack Number 2W98R6 with Lot no. 0412002558; Catalog/Customer Pack Number 2Y74R2 with Lot no. 0501000436; Catalog/Customer Pack Number 2Y78R5 with Lot no.''s 0412001590 and 0501002781; Catalog/Customer Pack Number 3D21R1 with Lot no. 0411006924; Catalog/Customer Pack Number 3F11R2 with Lot no. 0412005199; Catalog/Customer Pack Number 3F83R1 with Lot no.''s 0412002171, 0412003472 and 0412004460; Catalog/Customer Pack Number 3L07R2 with Lot no. 0501004498; Catalog/Customer Pack Number 3Q80R3 with Lot no. 0412003468; Catalog/Customer Pack Number 3R14R4 with Lot no. 0502001780; Catalog/Customer Pack Number 3S01R4 with Lot no. 0502002361; Catalog/Customer Pack Number 3S79R2 with Lot no. 0411006608; Catalog/Customer Pack Number 3V39R with Lot no. 0411006910; Catalog/Customer Pack Number 4B19R3 with Lot no. 0502001785; Catalog/Customer Pack Number 4B82R with Lot no. 0501005425; Catalog/Customer Pack Number 9015R8 with Lot no. 0411003414; Catalog/Customer Pack Number 9063R9 with Lot no. 0501002505; Catalog/Customer Pack Number 9251R16 with Lot no.''s 0411003749 and 0412004062; Catalog/Customer Pack Number CB0M50R2 with Lot no.''s 0411006331 0412000701 and 0412003740; Catalog/Customer Pack Number CB0R21R2 with Lot no. 0411005057; Catalog/Customer Pack Number CB0S15R7 with Lot no.''s 0411004246, 0412003181 and 0501004470; Catalog/Customer Pack Number CB1C78R11 with Lot no.''s 0411005055 and 0412001564; Catalog/Customer Pack Number CB2690-1 with Lot no. 0411002434; Catalog/Customer Pack Number CB2C36R10 with Lot no. 0412001209; Catalog/Customer Pack Number CB2E68R3 with Lot no.''S 0411006933 and 0412005212; Catalog/Customer Pack Number CB2H63R5 with Lot no. 0412003184; Catalog/Customer Pack Number CB2K05R4 with Lot no.''S 0411003199 and 0412001229; Catalog/Customer Pack Number CB2Z67R2 with Lot no. 0412005211; Catalog/Customer Pack Number CB3L15R3 with Lot no. 0411005056; Catalog/Customer Pack Number CB3Q10R1 with Lot no. 0501004457; Catalog/Customer Pack Number CB3T25R2 with Lot no. 0501005426; Catalog/Customer Pack Number CB3U51R2 with Lot no. 0411006084; Catalog/Customer Pack Number CB3U51R5 with Lot no.''s 0501000085 and 0501000443; Catalog/Customer Pack Number CB3W16R3 with Lot no. 0502001415; Catalog/Customer Pack Number CB3Z05R with Lot no.''s 0411006935 and 0502002616; Catalog/Customer Pack Number CB4B28R with Lot no. 0501002773; Catalog/Customer Pack Number HY2J04R2 with Lot no. 0412000923; Catalog/Customer Pack Number HY2U30R3 with Lot no. 0411001294 and 0501001294; Catalog/Customer Pack Number HY3E77R6 with Lot no.''s 0410008224, 0412001560 and 0501002937; Catalog/Customer Pack Number HY3Y36R with Lot no. 0501003677; Catalog/Customer Pack Number TL2K47R3 with Lot no.''s 0411003194 and 0412003178; Catalog/Customer Pack Number TL2M65R1 with Lot no. 0410003692; Catalog/Customer Pack Number TL2P93R1 with Lot no.''s 412001991, 0501002979 and 0502002686; Catalog/Customer Pack Number TL2P94R6 with Lot no. 0412000922; Catalog/Customer Pack Number TL2Q00R6 with Lot no. 0411003751; Catalog/Customer Pack Number TL2Q02R6 with Lot no. 0412002584; Catalog/Customer Pack Number TL2S57R3 with Lot no. 0411006070; Catalog/Customer Pack Number TL3B47R8 with Lot no.''s 0411004731 and 0412005219; Catalog/Customer Pack Number TL3C36R1 with Lot no. 0501001293; Catalog/Customer Pack Number TL3C66R4 with Lot no. 0412003164; Catalog/Customer Pack Number TL3F46R1 with Lot no. 0502000857; Catalog/Customer Pack Number TL3G03R1 with Lot no. 0411004739; Catalog/Customer Pack Number TL3G34R with Lot no.''s 0411004988 and 0411006937; Catalog/Customer Pack Number TL3H76R7 with Lot no.''s 0411004741 and 0501001692; Catalog/Customer Pack Number TL3P08R with Lot no.''s 0411003748 and 0412005195; Catalog/Customer Pack Number TL3R32R with Lot no. 0411006939; Catalog/Customer Pack Number TL3R59R4 with Lot no. 0411003763; Catalog/Customer Pack Number TL3Z67R2 with Lot no.''s 0412004544 and 0501000804; and Catalog/Customer Pack Number TL4A82R with Lot no. 0411006604.  TOTAL SYSTEMS:  Total System TS8184R9 with Lot no.''s 11323584, 11281448, 11262323, 11229369 and 11189019; Total System TS8161R6 with Lot no.''s 11301690, 11271898, 11190528 and 11376510; Total System TS8163R7 with Lot no.''s 11294151, 11278357, 11249648, 11235370, 11209905, 11172365, 11159434, 11127913 and 11092587 ; Total System TS9632R32 with Lot no.''s 11314733, 11264825 and 11199673; Total System TS9422R30 with lot no.''s 11085227, 11101188, 11022556, 11369433, 11208288 and 11151238A; Total System TS1265R6 with Lot no.''s 11344914, 11341867, 11216620 and 11213665; Total System TS1231R10 with Lot no.''s 11276692, 11036456 and 11007721; Total System TS8240R3 with Lot no.''s 11348660 and 11271850; Total System TS8258R1 with Lot no.''s 11361686 and 11343264; Total System TS8151R7 with Lot no.''s 11281057, 11259915, 11245459, 11236224, 11209834 and 11196880; Total System TS8009R7 with Lot no.''s 11432303, 11389716B, 11365733, 11365733B, 11353727, 11297859, 11277544A, 11388228, 11389716B, 11384983A, 11365733B and 11374909; Total System TS8101R5 with Lot no.''s 11355174, 11326135, 11280917, 11261447, 11246651, 11233518, 11219744, 11187093, 11154628, 11148913, 11146030 and 11025969; Total System TS8387R with lot no. 10935463; Total System TS 8363R with lot no.''s 11232452, 11209241, 11170011, 11134085, 11044590, 11280218, 11355877A, 11319313, 11362213, 11335475, 11322560, 11277524 and 11221479; Total System TS8275R2 with Lot No.''s 11143684, 11117484, 11113585 and 11078654; Total System TS8287R with Lot no. 11304060; Total System TS8299R with Lot no.''s 11237797 and 11207329; Total System TS8385R with lot no.''s 10890724 and 11157079A; Total System TS8329R3 With Lot no.''s 11319074, 11282455, 11269241, 11260213, 11237174, 11211041, 11355036 and 11326059; Total System TS8339R1 with Lot no.''s 11240930, 1161677 and 11364737; Total System TS8394R1 with Lot no. 11275457; Total System TS8329R3 with Lot no.''s 11454233, 11435228, 11404947 and 11392251; Total System TS8390R with Lot no. 11019052; and Total System TS 8367R1 with Lot no.''s 11247834, 11107184, 11063353, 11033869, 11355872, 11278049 and 11144479.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    nationwide, Canada, Australia, Japan and Latin America
  • Descripción del producto
    Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Manufacturer: Medtronic , Inc. Minneapolis, MN 55432-5604 USA
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • Dirección del fabricante
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA