Medex Inc

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.

Cardiovascular Devices

2

No

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.

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

All of the following lot codes are affected: Lot Numbers: 30J030048, 30K150054, 31A030144, 31b120110, 31B355998, 31C190086, 31c260053, 31D300042, 31F80073, 31I240006, 31J220068, 32C250072, 32H050182, 32K050108, 33f030089, 33G210028, 33J270026, 34C01D100, 34G01D063, 35A04D101, 35A31D040, 35C29D125

Cardiovascular Devices

2

No

The recalled device was distributed to customers throughout the U.S.A. and in Canada.

MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**medex Dublin, OH 43016 USA**STERILE***MX441B CVP Manometer**Lot#***Latex Free''

All Lot codes listed as follows are affected: 30K200116, 31A160060, 31A250027, 31B280077, 31E160051,31H030002, 31I140023, 31J050052,31J250065, 32C070041, 32I050037, 32K250019, 33A300046, 33C170028, 33E290076, 33H220008, 3L170057, 34B16D038, 34B26D062, 34E05D055, 34F09D079, 34H05D023, 34H25D034, 34T17D091,34J14D021, 34L16D040

Neurological Devices

2

No

The recalled device was distributed to a single direct account customer located in Alabama and to

MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''

reorder no. 7022, lot K307

Anesthesiology Devices

1

No

California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.

Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84'' Tube; reorder no. 7022; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

reorder no. 7020, lots K235, K277A, J135R, J142, M196, M337, N107

Anesthesiology Devices

1

No

California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.

Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008