FDA Medical Device Recalls (openFDA)
Medex Inc: 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
- Recall number
- Z-0198-05
- Recalling firm
- Medex Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2004-10-20
- Posted
- 2004-11-16
- Terminated
- 2012-04-11
- Reason
- Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.
- Root cause
- Other
- 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.
- Quantity
- 71,132 units.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K902771"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 1526863
- Firm city
- Dublin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28