17 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KERBOULL CROSS
FDA 510(k)
FDA Class 2
·Orthopedic
Plum
FDA UDI
ICU Medical, Inc.·10887787009009·CONVERTIBLE DUAL CHANNEL PLUMSET WITH CLAVES, A...
LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
Portable X-ray System
FDA 510(k)
FDA Class 2
·Dental
LC4200 PCA PLUS AUST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012
LC4200 PCA AUST
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·October 20, 2010
PCA PUMP (AUZ)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012
LC4200 PCA PLUS AUST
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012
PCA PUMP (AUZ)
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·June 2, 2010
PERCUTANEOUS THROMBOLYTIC DEVICE KIT
FDA Adverse Event
Malfunction
·ARROW INTERNACIONAL INC.·Product code DXE·April 28, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·February 21, 2013
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·January 28, 2011
*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·July 6, 2016
*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·September 9, 2013
*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML; *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; *** 4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP; *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML; *** 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML; *** 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA; *** 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 11) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 12) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 13) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·September 9, 2013
*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML; *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; *** 4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP; *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML; *** 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML; *** 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA; *** 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 11) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 12) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 13) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·July 6, 2016
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS609; 6) STERILE ANGIOGRAPHY PACK, Catalog Number SAN13BS60K; 7) ANGIOGRAPHY PACK, Catalog Number SAN13BS60L; 8) ANGIOGRAPHY PACK, Catalog Number SAN13BS60M; 9) ANGIOGRAPHY PACK, Catalog Number SAN13BS60N; 10) ANGIOGRAPHY PACK, Catalog Number SAN13BS60O; 11) CATH LAB PACK, Catalog Number SAN13CLET2; 12) CATH LAB PACK, Catalog Number SAN13CLETC; 13) CATH LAB PACK, Catalog Number SAN13CLETD; 14) ARTERIOGRAM PACK, Catalog Number SAN21AGE10; 15) ARTERIOGRAM PACK, Catalog Number SAN21AGEG6; 16) ARTERIOGRAM PACK, Catalog Number SAN21AGEG7; 17) ARTERIOGRAM PACK, Catalog Number SAN21AGEG8; 18) ARTERIOGRAM PACK, Catalog Number SAN21AGEG9; 19) ARTERIOGRAM PACK, Catalog Number SAN21AGEGJ; 20) ARTERIOGRAM PACK, Catalog Number SAN21AGEGK; 21) ARTERIOGRAM PACK, Catalog Number SAN21AGEGL; 22) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ10; 23) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ11; 24) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ12; 25) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ13; 26) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ14; 27) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ15; 28) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ16; 29) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ17; 30) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ18; 31) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ19; 32) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC6; 33) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC7; 34) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC8; 35) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC9; 36) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJCH; 37) CVL PACK, Catalog Number SAN22CVW12; 38) CVL PACK, Catalog Number SAN22CVW14; 39) CVL PACK, Catalog Number SAN22CVW15; 40) CVL PACK, Catalog Number SAN22CVW16; 41) CVL PACK, Catalog Number SAN22CVW17; 42) CVL PACK, Catalog Number SAN22CVW18; 43) CVL PACK, Catalog Number SAN22CVW19; 44) CVL PACK, Catalog Number SAN22CVW20; 45) CVL PACK, Catalog Number SAN22CVWRK; 46) CVL PACK, Catalog Number SAN22CVWRL; 47) ACCESSORY PACK, Catalog Number SAN37ASMO3; 48) ACCESSORY PACK, Catalog Number SAN37ASMO4; 49) ACCESSORY PACK, Catalog Number SAN37ASMO5; 50) ACCESSORY PACK, Catalog Number SAN37ASMOE; 51) ACCESSORY PACK, Catalog Number SAN37ASMOF; 52) ACCESSORY PACK, Catalog Number SAN37ASMOG; 53) ACCESSORY PACK, Catalog Number SAN37ASMOH; 54) PEDIATRIC CARDIAC CATH PACK, Catalog Number SAN57PD00K; 55) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS10; 56) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS11; 57) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSM7; 58) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM8; 59) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM9; 60) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSMK; 61) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSML; 62) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSMN; 63) CATH PACK, Catalog Number SAN73CHS10; 64) CATH PACK, Catalog Number SAN73CHS11; 65) CATH PACK, Catalog Number SAN73CHSJ5; 66) CATH PACK, Catalog Number SAN73CHSJ6; 67) CATH PACK, Catalog Number SAN73CHSJ7; 68) CATH PACK, Catalog Number SAN73CHSJ8; 69) CATH PACK, Catalog Number SAN73CHSJ9; 70) CATH PACK, Catalog Number SAN73CHSJJ; 71) CATH PACK, Catalog Number SAN73CHSJK; 72) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSB; 73) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSC; 74) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGR4; 75) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRJ; 76) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRK; 77) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA13; 78) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA14; 79) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA15; 80) ANGIOGRAPHY DRAPE PACK CMC,
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·July 17, 2024