Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medex Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30268
  • Event Risk Class
    Class 2
  • Event Number
    Z-0198-05
  • Event Initiated Date
    2004-10-20
  • Event Date Posted
    2004-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35588
  • Notes / Alerts
    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.
  • Extra notes in the data
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Reason
    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.
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Medex Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Source
    USFDA