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    POLISH PLUS

    FDA UDI
    MICRON CO.,LTD.·04560205914220·

    POLISH PLUS

    FDA UDI
    MICRON CO.,LTD.·04560205914213·

    POLISH PLUS

    FDA UDI
    MICRON CO.,LTD.·04560205914206·

    POLISH PLUS

    FDA UDI
    MICRON CO.,LTD.·04560205914237·

    POLISH PLUS

    FDA UDI
    MICRON CO.,LTD.·04560205914190·

    PROFEMUR® STEM EXT 26MM X 23MM DIA

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code MRA·July 7, 2025

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 14, 2012

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·May 5, 2014

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·May 5, 2014

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·December 6, 2010

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 14, 2011

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·April 14, 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

    Adjunctive Cardiovascular Status Indicator

    FDA classification
    FDA Class 2 ·Adjunctive Cardiovascular Status Indicator

    *** 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

    HU-FRIEDY

    FDA UDI
    HU-FRIEDY MFG. CO., LLC·10889950049478·Wakefield Gauze Packer

    Intra-Lock

    FDA UDI
    INTRA-LOCK INTERNATIONAL, INC.·D742BPW0·Bone Profiler Wide Platform

    EPW FOLDABLE POWER WHEELCHAIR, EPW-03

    FDA 510(k)
    FDA Class 2 ·Physical Medicine