Events

Retiro De Equipo (Recall) de LIifeShield CLAVE

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 Hospira Inc..

¿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
    66372
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2058-2016
  • Fecha de inicio del evento
    2013-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122209
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Set, administration, intravascular - Product Code FPA
  • Causa
    Intravenous fluid may leak at the clave secondary port of hospira plumset iv administration sets.
  • Acción
    Hospira sent an URGENT MEDICAL DEVICE CORECTION letters dated September 9, 2013 to customers. The letter identified the affected product, problem and actions to be taken. the letter included additional instructions on the proper handling/use of the CLAVE devices. The letters request that all incidents of separation or breakage of CLAVE from the secondary port of the cassette be reported to Hospira by calling 1-800-441-410 (Monday - Friday, 8:00 AM - 5:00 PM CST) or by e-mail at ProductComplaintPP@hospira.com. Customers are further requested to complete and return a response form included wih the URGENT MEDICAL DEVICE CORRECTION letter and to notify any customers of this advisory. Hospira will also be supplementing the instructions for CLAVE use as an interim measure until a new method for bonding the CLAVE to the secondary port of the Plum cassettes can be devised and implemented.

Device

LIifeShield CLAVE
  • Modelo / Serial
    ***** US DISTRIBUTION *****   *** 1) List Number: 14212-04-28; Lot Numbers:  962235H , 030565H , 030575H , 081425H , 090515H , 100905H , 100915H , 102255H , 102265H , 122515H , 122525H , 143405H , 152655H , 152665H , 152675H , 161375H , 161385H , 161395H , 170955H , 172025H , 172035H , 172045H , 143415H , 241805H , 251735H , 251745H , 250845H ;  *** 2) List Number: 14254-08-28; Lot Number:  072055H;  *** 3) List Number: 14687-04-28; Lot Numbers:  650935H , 710435H , 720925H , 721925H , 721895H , 721325H , 721905H , 730175H , 761965H , 771895H , 772175H , 780725H , 781395H , 780715H , 800135H , 800145H , 810185H , 851685H , 840795H , 861775H , 861785H , 810155H , 880695H , 901065H , 901055H , 901095H , 921945H , 020765H , 020775H , 020785H , 020795H , 030185H , 030195H , 042005H , 052335H , 052755H , 052345H , 061035H , 070625H , 080325H , 080335H , 091085H , 092935H , 132125H , 142805H , 153285H , 153495H , 171435H , 180405H , 211275H , 201225H , 201235H ;    ***** FOREIGN DISTRIBUTION *****   *** 4) List Number: 12193-83-24; Lot Numbers:  662095H , 712345H , 741615H , 880705H , 890735H , 920595H , 952665H , 020485H ;  *** 5) List Number: 12193-92-28; Lot Numbers:  063285H , 071115H , 071475H , 133335H , 140205H , 171535H , 180045H , 250515H , 281895H ;  *** 6) List Number: 19194-83-24; Lot Numbers:  662115H , 702305H , 721795H , 721805H , 732055H , 732035H , 732045H , 732065H ;  *** 7) List Number: 19194-84-24; Lot Numbers:  881945H,  950975H;  *** 8) List Number: 12194-92-28; Lot Numbers:  071105H , 140085H , 151445H , 180055H ;  *** 9) List Number: 12195-83-24; Lot Numbers:  662105H , 712355H , 821545H , 880715H , 890745H , 910745H ;  *** 10) List Number: 12195-84-24; Lot Numbers:  681645H , 681655H , 702295H , 721695H , 721785H , 741635H , 741355H , 761495H , 771395H , 782265H , 782275H , 791315H , 890755H , 900455H , 940615H , 951325H , 010725H , 011475H , 020895H , 021415H ;  *** 11) List Number: 12195-92-28; Lot Numbers:  063185H , 063195H , 071125H , 102395H , 102405H , 111705H , 111715H , 113055H , 112865H , 131865H , 133405H , 140115H , 153385H , 162385H , 171445H , 180065H , 180075H , 200855H , 210865H , 201895H , 221315H , 250525H , 260235H , 271645H , 270825H ;  *** 12) List Number: 12196-83-24; Lot Numbers:  662125H , 702315H , 702325H , 712245H , 712255H ;  *** 13) List Number: 12196-84-24; Lot Number:  871295H;  *** 14) List Number: 12196-92-28; Lot Numbers:  071135H , 131835H , 151545H , 211645H , 250505H , 281575H ;  *** 15) List Number: 14001-07-28; Lot Numbers:  810195H , 810205H , 831395H , 830775H , 890985H , 902085H , 220125H ;  *** 16) List Number: 14001-82-28; Lot Numbers:  890945H , 932935H , 151585H ;  *** 17) List Number: 14001-83-28; Lot Numbers:  752235H , 851525H , 871535H , 890765H , 900465H , 910215H , 951335H , 960405H , 010735H , 010755H , 020905H , 032185H , 040965H , 053775H , 061775H ;  *** 18) List Number: 14001-84-28; Lot Numbers:  752254H , 830785H , 851515H , 890775H , 950355H ;  *** 19) List Number: 14001-92-28; Lot Numbers:  063255H , 081605H , 081615H , 091115H , 161615H , 162365H , 180395H , 190925H , 220155H , 190935H , 190945H ;  *** 20) List Number: 14007-82-01; Lot Numbers:  811595H,  160345H;  *** 21) List Number: 14007-92-28; Lot Numbers:  251485H,  270875H;  *** 22) List Number: 14009-82-01; Lot Numbers:  811525H,  840885H,  910095H;  *** 23) List Number: 14011-82-01; Lot Number:  811555H;  *** 24) List Number: 14012-92-28; Lot Numbers:  162315H,  231615H;  *** 25) List Number: 14013-82-01; Lot Numbers:  811535H,  840895H,  920855H;  *** 26) List Number: 14014-92-28; Lot Number:  162305H;  *** 27) List Number: 14015-82-01; Lot Numbers:  811515H,  910105H;  *** 28) List Number: 14017-82-01; Lot Number:  811705H;  *** 29) List Number: 14017-92-28; Lot Numbers:  112855H,  200955H;  *** 30) List Number: 14022-92-28; Lot Numbers:  162325H,  172265H;  *** 31) List Number: 14212-92-28; Lot Numbers:  071955H , 091685H , 100885H , 110505H , 113655H , 143425H , 161415H ;  *** 32) List Number: 19673-53-24; Lot Numbers:  662035H , 701715H , 721575H , 910115H , 910515H , 961555H , 011455H , 031335H , 061995H , 102145H , 111615H , 132705H , 180615H , 201815H , 220725H , 200275H , 241365H
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (Nationwide) Distribution
  • Descripción del producto
    *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; || *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP; || Product Usage: || The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA