Class 2 Device Recall Medex Closed Blood Sampling kits and pressure monitoring sets which contain the blood sampling port.

• Date Initiated by Firm: October 20, 2004
• Date Posted: November 16, 2004
• Recall Status: Terminated on April 11, 2012
• Recall Number: Z-0198-05
• Recall Event ID: 30268
• 510(K)Number: K902771
• Product Classification: Catheter, Intravascular, Diagnostic - Product Code DQO
• 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
• Code Information: 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.
• Recalling Firm/ Manufacturer: Medex Inc; 6250 Shier Rings Rd; Dublin OH 43016-1270
• For Additional Information Contact: Terri Davis; 800-848-1757 Ext. 5542
• Manufacturer Reason for Recall: Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQO