Events

Rappel de Medex Closed Blood Sampling kits and pressure monitoring sets which contain the blood sampling port.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medex Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    30268
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0198-05
  • Date de mise en oeuvre de l'événement
    2004-10-20
  • Date de publication de l'événement
    2004-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35588
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Cause
    Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.
  • Action
    The firm sent certified letters on October 20 & 21, 2004 to all customers to whom the product was sent directly and to all distributors to whom Medex shipped the product directly in the United States. Customers in foreign countries were notified via Fed Ex.

Device

Medex Closed Blood Sampling kits and pressure monitoring sets which contain the blood sampling port.
  • Modèle / numéro de série
    MX20170: Lot #s 33D160090, 33J100011,34A12D017, 34D28D092.  MX20443: Lot #s 32J240054, 32K140054, 32L110056, 32L260051, 33A160015, 33B120027, 33B260040, 33C200060, 33D090064, 33D230066, 33E210102, 33E290113, 33F110010, 33G240058, 33H080024, 33I040010, 33J020029, 33J160008, 33J230033, 33K120027, 33L030054, 34B04D092, 34B16D019, 34B26D023, 34C11D001.   MX20470: Lot 34A22D075.  MX20477: Lot #s 33D020091, 33K120026.  MX20730: Lot #s 33C050084, 33D110030, 33E010093, 33F030094, 33G030104, 34A12D137, 34C31D055.  MX20760: Lot #''s 33C270065, 33I230822, 33K100055, 33K240050, 34A12D082, 34B26D099, 34C04D029.   MX20822: Lot #''s 33I090048, 34A22D110.  MX4033: Lot #''s 32L120073, 33A06143, 33A080077, 33B040079, 33C040104, 33C270062, 33D250039, 33E050044, 34B02D072, 34C08D038.  MX4037: Lot #''s 33A080069, 33B110006, 33C270063, 33D220026, 33F020063, 33G080019, 33G230005, 33J140016, 34A26D108, 34C08D034.  MX700376: Lot 33A2220390.  MX700377: Lot #''s 33A2220392, 33A2920402.   MX7781R1: Lot #''s 32L040106, 33H080048.  MX8004CSTT: Lot 33K140086.   MX8033T: Lot #''s 32L040021, 33B040050, 33H220097, 34B03D044.  MX9502CSTT: Lot #''s 32K150075, 33A310026, 33G150105, 33K250018, 34B04D014.  MX9504CSTT: Lot #''s 32J250089, 32L050045, 33A240034, 33B130060, 33C060003, 33D280078, 33F040042, 33H140037, 33H200018, 34A26D097.  MX9505CSTT: Lot #''s 33D2322860, 34C22D067.   MX9506CSTT: Lot 33L020058.  MX9533T: Lot #''s 32K260078, 33A090065, 33C140050, 33E290013, 33H070093, 33I090014, 33K040033, 33L020068, 34A26D098, 34B25D049, 34C30D034, 34D27D047.  MX9534T: Lot #''s 33A160085, 33B250064, 33D100061, 33F250042, 33H140048, 33J070023.   MX9537T: Lot #''s 33A090071, 33B250065, 33D230022, 33F100153, 33G090033, 33H070089, 33I020046, 33J070024, 33K180032, 34A15D040, 34B04D022, 34B16D081, 34C03D039.  MX9602CSTA: Lot #''s 32K150073, 33A240039, 33D160033, 33G090027, 33G230029.   MX9604CSTA: Lot #''s 33A240037, 33A310028, 33C140029, 33D100058, 33F040040, 33L190038.  MX9605CSTA: Lot #''s 32J310063, 32L270023, 33B250063, 33C140031, 33D100054, 33E290017, 33F100155, 33F250061, 33G300021, 33H140043, 33I300032, 33K180035, 33L190036, 34A26D089, 34B19D098.  MX9606CSTA: Lot #''s 32L050050, 33A090069, 33A310031, 33C060008, 33C200010, 33D230031, 33E130048, 33F250040, 33G230030, 33H140044, 33I170051, 33K040035, 33K250040, 34A12D037, 34A26D083, 34B16D083, 34C03D040.  MX9607CSTA: Lot #''s 32J300018, 33E050037, 33J280007, 34B02D043.  MX9634A: Lot #''s 33A160083, 33A310034, 33C200011, 33D100072, 33E280100, 33G230025, 33I170052, 33K180034, 33L190040, 34A26D099, 34B25D046.  MX9637A: Lot #''s 33A160084, 33B130050, 33D230021, 33E200059, 33F170096, 33K250042, 34A26D086, 34C03D036.  SX02: Lot 33G080023.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed throughout the United States to distributors and hospitals located in FL, PA, CA, NE, SC, NY, MO, NM, GA, IL, MN, NC, Washington DC, RI, CO, MS, WI, HI, TX, MI, VA, WA, NJ, KY, MA, LA, TN, AZ, MD, OR, PR, UT, TN, OH, AL, IN, NV, OK and to foreign accounts located in Mexico, TMP, Ecuador, Brazil, LKA, Thailand, New Zealand, Australia, and Canada.
  • Description du dispositif
    MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, || MX20443: LogiCal Single Pressure Kit, || MX20470: Pressure Monitoring Kit, || MX20477: LogiCal Double Kit, || MX20730: Double LogiCal Kit, || MX20760: Neonatal 18'' Add-On Kit, || MX20822: TranStar Monitoring Set, || MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, || MX4037: Kids Kit Add-On Blood Sampling Kit, || MX700376: TranStar Triple Monitoring Kit, || MX700377: Double TranStar Kit, || MX7781R1: St Judes Secure Kit, || MX8004CSTT: Novatrans Mtring Kit 60 (152.4cm) Single Line, || MX8033T: Novatrans Kids Kit Neonatal Mtring, || MX9502CSTT: TranStar 72in (183cm) Secure Double Kit, || MX9504CSTT: TranStar 60in (152cm) Secure Monitoring Kit, || MX9505CSTT: TranStar 84in (213) Secure Monitoring Kit, || MX9506CSTT: TranStar 72in Secure Triple Kit, || MX9533T: TranStar Kids Kit Neonatal Monitoring Kit, || MX9534T: TranStar Kids Kit, || MX9537T: TranStar Kids Kit, || MX9602CSTA: LogiCal 72in (183cm) Secure Double Kit, || MX9604CSTA: LogiCal 60in (152cm) Secure Monitoring Kit, || MX9605CSTA: LogiCal 84in (213cm) Secure Monitoring Kit, || MX9606CSTA: LogiCal 72in (183cm) Secure Monitoring Kit, || MX9607CSTA: LogiCal Triple Secure Kit, || MX9634A: LogiCal Kids Kit Neonatal Monitoring Kit, || MX9637A: LogiCal Kids Kit Neonatal Monitoring Kit, || SX02: Sterile Sample
  • Manufacturer
    Medex Inc

Manufacturer

Medex Inc
  • Adresse du fabricant
    Medex Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Source
    USFDA