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    Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DYNJ0619768D CARDIAC PROCEDURE PACK DYNJ63700 CLOSURE CDS CDS983704D CLOSURE CDS CDS983704F CLOSURE CDS CDS983704G COLECTOMY LAPAROSCOPIC DYNJ906875 COLORECTAL ME DYNJ906437 CRANIOTOMY DYNJ905330A CRANIOTOMY DYNJ905330B C-SECTION PACK DYNJ32884F C-SECTION PACK DYNJ32884G C-SECTION PACK DYNJ32884I C-SECTION PACK DYNJ32884J C-SECTION TRAY DYNJ62707 CYSTO DYNJ901329B CYSTO DYNJ901608B CYSTO DYNJ903225I CYSTO CDS982015O CYSTO DYNJ903225J CYSTO CDS982015P CYSTO DYNJ903225K CYSTO DYNJ906481 CYSTO DYNJ903225L CYSTO CDS CDS985376C CYSTO CDS-LF CDS982481I CYSTO CDS-LF CDS982481J CYSTO CDS-LF CDS982481K CYSTO CDS-LF CDS982481L CYSTO PACK DYNJ05177G CYSTO PACK DYNJ51350A CYSTO PACK DYNJ37252F CYSTO PACK DYNJV0052L CYSTO PACK DYNJ37680D CYSTO PACK DYNJ58223 CYSTO PACK DYNJ53570A CYSTO PACK CMPJ01845I CYSTO PACK DYNJ37252G CYSTO PACK DYNJ37252I CYSTO PACK-LF DYNJ24911D CYSTO PACK-LF CMPJ02168J CYSTO PACK-LF DYNJ30470B CYSTO PACK-LF CMPJ02168K CYSTO PACK-LF DYNJ51350B CYSTO PACK-LF DYNJ51350C CYSTO TRAY-LF DYNJ42146A CYSTO/UROLOGY PACK DYNJ64197 CYSTO-LF DYNJ50098 CYSTOSCOPY-LF DYNJ22891I D&C HYSTEROSCOPY DYNJ901049B D&C HYSTEROSCOPY DYNJ901049C D&C HYSTEROSCOPY DYNJ901049D D&C HYSTEROSCOPY PACK CMPJ43148C D&C HYSTEROSCOPY PACK CMPJ43148D D&C HYSTEROSCOPY PACK CMPJ43148F D&C PACK DYNJ33603D D&C PACK DYNJ22567C D&C PACK DYNJ22567D D&C PACK DYNJ55814B D&C PACK-LF DYNJ22567F D&C/GYN-LF DYNJ61949 D&C/GYN-LF DYNJ61949A D&C-LF DYNJ50099A D&C-LF DYNJ906482 DELIVERY PACK SMMC-LF DYNJ35244D DELIVERY PACK SMMC-LF DYNJ35244F DENTAL ENT PACK-LF DYNJ43405B DR H PACK DYNJ62374 DR. S PACK DYNJ60499 EAR DYNJ906058A EAR DYNJ906058B EAR DYNJ906058F GEN PLASTIC DYNJ901298A GENERAL DELIVERY PACK-LF DYNJ15915F GENERAL PACK DYNJ37894B GENERAL PACK DYNJ61784 G S CYSTO PACK DYNJ62403 G CYSTO CDS CDS984190G G CYSTO CDS CDS984190I G CYSTO CDS CDS984190J G D & C CDS CDS984203F G D & C CDS CDS984203G G D & C CDS CDS984203I G D & C CDS CDS984203J G LASER VEIN CDS CDS984193M G LASER VEIN CDS CDS984193N G PELVISCOPY CDS CDS984187M G PELVISCOPY CDS CDS984187N G PELVISCOPY CDS CDS984187O G PELVISCOPY CDS CDS984187P G VAGINAL CDS CDS984201M G VAGINAL CDS CDS984201O G VAGINAL CDS CDS984201P G VAGINAL CDS CDS984201Q GU SEED PACK-RF-LF DYNJ01631F GU-GEN ROBOTIC PACK CMPJ11121 GYN LAPAROSCOPY DYNJ903869 GYN LAPAROSCOPY DYNJ901636B GYN LAPAROSCOPY DYNJ902101A GYN LAPAROSCOPY DYNJ37256D GYN LAPAROSCOPY DYNJ903869A GYN LAPAROSCOPY DYNJ903869B GYN LAPAROSCOPY DYNJ903869C GYN LAPAROSCOPY DYNJ903869D GYN LAPAROSCOPY CDS CDS983410C GYN LAPAROSCOPY CDS CDS985217D GYN LAPAROSCOPY CDS CDS983410D GYN LAPAROSCOPY CDS CDS985217F GYN LAPAROSCOPY CDS CDS983410F GYN LAPAROSCOPY CDS CDS985217G GYN LAPAROSCOPY PACK DYNJ48614C GYN LAPAROSCOPY PACK DYNJ22568F GYN LAPAROSCOPY PACK DYNJ22568G GYN LAPAROSCOPY PACK DYNJ37337G GYN LAPAROSCOPY PACK-LF DYNJ22568I GYN LAPAROSCOPY/LAVH CDS CDS981294C GYN LITHOTOMY PACK DYNJ48615B GYN ONCOLOGY ME DYNJ900201G GYN ROBOTIC DYNJ903282D GYN ROBOTIC DYNJ903282F GYN ROBOTIC DYNJ903282G GYN ROBOTIC DYNJ903282I GYN ROBOTIC DYNJ903282J GYN ROBOTIC DYNJ903282L GYN-URO LAPAROSCOPY DYNJ904856 GYN-URO LAPAROSCOPY DYNJ904856A HEAD AND NECK PACK DYNJ46509C HEART PACK A&B CMPJ22236V HH PAIN CLINIC PACK DYNJ59488 HMT CY

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·May 27, 2020

    BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·August 14, 2024

    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013

    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013

    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013

    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013

    BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 155144-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 155145-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 155157-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P / 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 155153-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 155155-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 155147-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 155149-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 155150-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 169-114 BD PYXIS MEDBANK MINI CR-4HH-P / 169-115 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 169-83 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 169-85 BD PYXIS MEDBANK TWR MN CR-14HH-P / 169-86 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 169-89 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 169-91 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /169-93 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 169-95 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 169-99 BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 138913-01 BD PYXIS MEDBANK MINI CR-4HH-P / 138911-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P / 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P / 139002-01 BD PYXIS MEDBANK MN 200 CR-4HH-P / 139000-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P / 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P / 139018-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P / 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P / 139021-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P / 139022-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 138975-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 138976-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 138977-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 139085-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 138964-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 138965-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 138970-01 BD Pyxis QFill Replenishment Station / 138904-01 KIT BD PYXIS QFILL REPLENISHMENT STATION / 155197-01 MEDBANK UPOS211 AIO WIN10 QFILL 1.5 / 155215-05 OPT,MEDBANK,HD,WIN10,QFILL,CR / 131944-04 The BD Pyxis" MedBank" CUBIE" Replenishment Station is an Automated Dispensing Cabinet (ADC) that is intended to be used by a qualified and authorized user to replenish medications and supplies to a BD Pyxis" MedBank" cabinet.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·April 16, 2025

    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013

    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013

    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013

    SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·December 4, 2013

    BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-106, MEDBANK MINI 2HH-1FM/ 169-107, MEDBANK MINI 2HH-1FM MEDPASS/ 169-152, MEDBANK MINI 2HH-2HM/ 169-108, MEDBANK MINI 2HM-1FM/ 169-109, MEDBANK MINI 3HH-1FG/ 169-110, MEDBANK MINI 3HH-1HM/ 169-111, MEDBANK MINI 4HH/ 169-112, MEDBANK MINI 4HH MEDPASS/ 169-150, MEDBANK MINI 4HM/ 169-113, MEDBANK MINI CR-2HH-1FH-P/ 169-114, MEDBANK MINI CR-4HH-P/ 169-115, MB MINI MAIN CR/ 169-163, MB MINI MAIN W/CUBIE DRWS/ 169-159, MB MINI MAIN W/FH FALSE DRW/ 169-162, MB MINI MAIN W/HH FALSE DRW/ 169-161, MB MINI MAIN W/MATRIX DRWS / 169-160, MB MINI MAIN W/MP/ 169-164 Used with the following user guides: BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989), BD Pyxis MedBank Cabinet User Guide (DIR 10000414987), BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990)

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 10, 2024

    138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS MEDBANK MN 200 CR-4HH-P 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P 139018-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P 139021-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P 139022-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 155140-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 138975-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 169-83 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 138976-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 155143-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 169-85 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 138977-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 155144-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 169-86 BD PYXIS MEDBANK TWR MN CR-14HH-P 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 155145-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 139085-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 155147-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 169-89 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 138964-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 155149-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 169-91 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 155150-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 169-93 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 138965-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 155153-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 169-95 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 155155-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 138970-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 155157-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 169-99 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFLEX MN 1000 4HH-1FM 139049-01 BD PYXIS MEDFLEX MN 1000 4HH-4FM 139044-01 BD PYXIS MEDFLEX MN 1000 6FM 139039-01 BD PYXIS MEDFLEX MN 1000 6HH 139051-01 BD PYXIS MEDFLEX MN 1000 6HH-3FM 139164-01 BD PYXIS MEDFLEX MN 1000 8HH-2FH 139052-01 BD PYXIS MEDFLEX MN 1000 8HH-2FM 139070-01 BD PYXIS MEDFLEX MN 2000 10HH-1FM 139071-01 BD PYXIS MEDFLEX MN 2000 12HH 139061-01 BD PYXIS MEDFLEX MN 2000 2HH-2FM 139066-01 BD PYXIS MEDFLEX MN 2000 2HH-3FM-1DD 139065-01 BD PYXIS MEDFLEX MN 2000 2HH-5FM 139058-01 BD PYXIS MEDFLEX MN 2000 3FM 139060-01 BD PYXIS MEDFLEX MN 2000 4HH-1FM 139067-01 BD PYXIS MEDFLEX MN 2000 4HH-4FM 139064-01 BD PYXIS MEDFLEX MN 2000 6FM 139059-01 BD PYXIS MEDFLEX MN 2000 6HH 139068-01 BD PYXIS MEDFLEX MN 2000 6HH-3FM 139165-01 BD PYXIS MEDFLEX MN 2000 8HH-2FH 139069-01 BD PYXIS MEDFLEX MN 2000 8HH-2FM 1139-00 MEDFLEX 2.0 1119-00 MEDFLEX

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 155160-01 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 169-102 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 138912-01 BD PYXIS MEDBANK MINI 1HH-3HM 155161-01 BD PYXIS MEDBANK MINI 1HH-3HM 169-103 BD PYXIS MEDBANK MINI 1HH-3HM 138902-01 BD PYXIS MEDBANK MINI 2FH 169-104 BD PYXIS MEDBANK MINI 2FH 138903-01 BD PYXIS MEDBANK MINI 2FM 155163-01 BD PYXIS MEDBANK MINI 2FM 169-105 BD PYXIS MEDBANK MINI 2FM 138908-01 BD PYXIS MEDBANK MINI 2HH-1FH 169-106 BD PYXIS MEDBANK MINI 2HH-1FH 138906-01 BD PYXIS MEDBANK MINI 2HH-1FM 155165-01 BD PYXIS MEDBANK MINI 2HH-1FM 169-107 BD PYXIS MEDBANK MINI 2HH-1FM 138907-01 BD PYXIS MEDBANK MINI 2HH-2HM 155166-01 BD PYXIS MEDBANK MINI 2HH-2HM 169-108 BD PYXIS MEDBANK MINI 2HH-2HM 139131-01 BD PYXIS MEDBANK MINI 2HM-1FM 155167-01 BD PYXIS MEDBANK MINI 2HM-1FM 169-109 BD PYXIS MEDBANK MINI 2HM-1FM 139091-01 BD PYXIS MEDBANK MINI 3HH-1FG 155168-01 BD PYXIS MEDBANK MINI 3HH-1FG 169-110 BD PYXIS MEDBANK MINI 3HH-1FG 138909-01 BD PYXIS MEDBANK MINI 3HH-1HM 155169-01 BD PYXIS MEDBANK MINI 3HH-1HM 169-111 BD PYXIS MEDBANK MINI 3HH-1HM 138910-01 BD PYXIS MEDBANK MINI 4HH 155310-01 BD PYXIS MEDBANK MINI 4HH 169-112 BD PYXIS MEDBANK MINI 4HH 138915-01 BD PYXIS MEDBANK MINI 4HM 155171-01 BD PYXIS MEDBANK MINI 4HM 169-113 BD PYXIS MEDBANK MINI 4HM 1147-00 MEDBANK MINI MAIN 138943-01 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 155081-01 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 169-23 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 138955-01 BD PYXIS MEDBANK TWR MN 10HH-2FH 155082-01 BD PYXIS MEDBANK TWR MN 10HH-2FH 169-24 BD PYXIS MEDBANK TWR MN 10HH-2FH 138924-01 BD PYXIS MEDBANK TWR MN 10HH-2FM 155083-01 BD PYXIS MEDBANK TWR MN 10HH-2FM 169-25 BD PYXIS MEDBANK TWR MN 10HH-2FM 138960-01 BD PYXIS MEDBANK TWR MN 12HH-1FF 155084-01 BD PYXIS MEDBANK TWR MN 12HH-1FF 169-26 BD PYXIS MEDBANK TWR MN 12HH-1FF 138961-01 BD PYXIS MEDBANK TWR MN 12HH-1FH 155085-01 BD PYXIS MEDBANK TWR MN 12HH-1FH 169-27 BD PYXIS MEDBANK TWR MN 12HH-1FH 138926-01 BD PYXIS MEDBANK TWR MN 12HH-1FM 155086-01 BD PYXIS MEDBANK TWR MN 12HH-1FM 169-28 BD PYXIS MEDBANK TWR MN 12HH-1FM 138927-01 BD PYXIS MEDBANK TWR MN 14HH 155087-01 BD PYXIS MEDBANK TWR MN 14HH 169-29 BD PYXIS MEDBANK TWR MN 14HH 155293-01 BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM 169-138 BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM 155303-01 BD PYXIS MEDBANK TWR MN 1FM-10HH-1FH 139082-01 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 155088-01 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 169-30 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 155305-01 BD PYXIS MEDBANK TWR MN 2FH-1FM-4HH-2FM 139056-01 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 155089-01 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 169-31 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 155304-01 BD PYXIS MEDBANK TWR MN 2FM-8HH-1FH 139045-01 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 155090-01 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 169-32 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 138932-01 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 155091-01 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 169-33 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 139084-01 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 155092-01 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 169-34 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 138963-01 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 155093-01 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 169-35 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 155294-01 BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM 169-139 BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM 138938-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 155094-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 169-36 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 139125-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 155095-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 169-37 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 138919-01 BD PYXIS MEDBANK TWR MN 2HH-6FM 155096-01 BD PYXIS MEDBANK TWR MN 2HH-6FM 169-38 BD PYXIS MEDBANK TWR MN 2HH-6

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025