BEUDAMED
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    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRAPHY PACK, Model Number: DYNJ65963; e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655; f. ARTHROGRAM TRAY, Model Number: SPEC0232; g. BASIC CATH/ANGIO, Model Number: DYNJ62591A; h. BASIC PACK, Model Number: DYNJ39752A; i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B; j. CATH ANGIO PACK, Model Number: DYNJ64050; k. DBD-KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148; l. DBS PACK-LF, Model Number: DYNJ0878178I; m. GENERAL ANGIO PACK, Model Number: DYNJ57760A; n. GHIASSI NEURO ANGIO PACK-LF, Model Number: DYNJ57032C; o. IR NEURO PACK, Model Number: DYNJ39198L, DYNJ39198N; p. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086A; q. MAIN BASIC NEURO, Model Number: DYNJ908260; r. NEURO ACCESSORY PACK, Model Number: DYNJ66790, DYNJ66790A, DYNJ66790B; s. NEURO CATH PACK, Model Number: DYNJ69129, DYNJ83090; t. NEURO IR PACK, Model Number: DYNJ35066I, DYNJ35066J, DYNJ60701A, DYNJ60701B, DYNJ60701C; u. NEURO PACK, Model Number: DYNJ43934A, DYNJ61798D, DYNJ66241, DYNJ66241A, DYNJ66241B, DYNJ66241C, DYNJ66241D, DYNJ68956A, DYNJ68956B; v. NEURO RADIOLOGY PACK, Model Number: DYNJ51107A, DYNJ59903A, DYNJ59903B; w. NEURO TRAY, Model Number: DYNJ67075, DYNJ67075A; x. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112A; y. PEDI ANGIO PACK-LF, Model Number: PHS41743B; z. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755C; aa. RADIOLOGY NEURO DRAPE PAC, Model Number: DYNJ61449; bb. RO-DIEP PACK, Model Number: DYNJ82393A;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJG·May 15, 2023

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Recall
    Terminated ·Synapse Biomedical Inc·Product code OIR·May 31, 2022

    NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.

    FDA Recall
    Terminated ·Synapse Biomedical Inc·Product code OIR·July 11, 2022

    Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.

    FDA Recall
    Terminated ·Apheresis Technologies, Inc.·Product code FIR·July 9, 2012

    Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    FDA Recall
    Terminated ·Apheresis Technologies, Inc.·Product code FIR·April 1, 2009

    American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic

    FDA Recall
    Terminated ·American Diagnostica, Inc.·Product code GIR·February 28, 2007

    PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    FDA Recall
    Terminated ·Apheresis Technologies, Inc.·Product code FIR·November 29, 2010

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code OSI·March 18, 2014

    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code OSI·March 18, 2014

    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code FNM·March 18, 2014

    ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

    FDA Recall
    Terminated ·Extended Care Air Therapy Systems Inc·Product code FNL·April 5, 2006

    Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS780056L ; 6) SHUNT CDS-LF, Pack Number CDS780103K ; 7) NEURO CDS , Pack Number CDS780108T ; 8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ; 9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ; 10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ; 11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ; 12) NEURO CDS , Pack Number CDS780162AA; 13) NEURO CDS , Pack Number CDS780162AB; 14) NEURO CDS , Pack Number CDS780162AC; 15) NEURO CDS , Pack Number CDS780162AD; 16) NEURO CDS , Pack Number CDS780162X ; 17) NEURO CDS , Pack Number CDS780162Y ; 18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ; 19) BASIC NEURO PACK, Pack Number CDS780202L ; 20) BASIC NEURO PACK, Pack Number CDS780202O ; 21) BASIC NEURO PACK, Pack Number CDS780202P ; 22) BASIC NEURO PACK, Pack Number CDS780202Q ; 23) BASIC NEURO PACK, Pack Number CDS780202R ; 24) NEURO-LAMI CDS, Pack Number CDS780208D ; 25) NEURO-LAMI CDS, Pack Number CDS780208F ; 26) NEURO CDS, Pack Number CDS780230K; 27) NEURO CDS , Pack Number CDS780230K ; 28) VP SHUNT, Pack Number CDS840193U ; 29) NEURO CDS-LF, Pack Number CDS980853N ; 30) VP SHUNT CDS-LF , Pack Number CDS981084K ; 31) VP SHUNT CDS-LF , Pack Number CDS981084L ; 32) VP SHUNT CDS-LF , Pack Number CDS981084M ; 33) NEURO KIT , Pack Number CDS981327N ; 34) NEURO KIT , Pack Number CDS981327O ; 35) NEURO KIT , Pack Number CDS981327P ; 36) NERVE STIMULATOR, Pack Number CDS981579N ; 37) NEURO MINOR CDS , Pack Number CDS981708K ; 38) VP SHUNT CDS, Pack Number CDS981740F ; 39) VP SHUNT CDS, Pack Number CDS981740J ; 40) VP SHUNT CDS, Pack Number CDS981740K ; 41) VP SHUNT CDS, Pack Number CDS981740KH; 42) MICRO DISC CDS, Pack Number CDS981886P ; 43) MICRO DISC CDS, Pack Number CDS981886R ; 44) MICRO DISC CDS, Pack Number CDS981886S ; 45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ; 46) NEURO CDS , Pack Number CDS982603L ; 47) NEURO CDS , Pack Number CDS982603M ; 48) NEURO CDS , Pack Number CDS982603N ; 49) NEURO SPINE CDS , Pack Number CDS982683Q ; 50) MAJOR NEURO , Pack Number CDS982704K ; 51) MAJOR NEURO , Pack Number CDS982704M ; 52) MAJOR NEURO , Pack Number CDS982704N ; 53) NEURO CDS CHS-LF, Pack Number CDS982745D ; 54) NEURO CDS CHS-LF, Pack Number CDS982745F ; 55) NEURO CDS CHS-LF, Pack Number CDS982745G ; 56) AV SHUNT CDS, Pack Number CDS983098D ; 57) AV SHUNT CDS, Pack Number CDS983098F ; 58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ; 59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ; 60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ; 61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ; 62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ; 63) VP SHUNT, Pack Number CDS983366J ; 64) VP SHUNT, Pack Number CDS983366M ; 65) VP SHUNT, Pack Number CDS983366N ; 66) VP SHUNT, Pack Number CDS983366P ; 67) NEURO CDS-LF, Pack Number CDS983383F ; 68) NEURO CDS-LF, Pack Number CDS983383G ; 69) NEURO CDS-LF, Pack Number CDS983383I ; 70) NEURO CDS-LF, Pack Number CDS983383J ; 71) AV SHUNT CDS, Pack Number CDS983792C ; 72) AV SHUNT CDS, Pack Number CDS983792D ; 73) ANTERIOR NEURO CDS, Pack Number CDS983882C ; 74) ANTERIOR NEURO CDS, Pack Number CDS983882D ; 75) POSTERIOR NEURO CDS , Pack Number CDS983885C ; 76) POSTERIOR NEURO CDS , Pack Number CDS983885D ; 77) POSTERIOR NEURO CDS , Pack Number CDS983885F ; 78) NEURO CDS , Pack Number CDS983981D ; 79) NEURO CDS , Pack Number CDS983981F ; 80) NEURO CDS , Pack Number CDS983981I ; 81) NEURO CDS , Pack Number CDS983981J ; 82) NEURO CDS , Pack Number CDS983981K ; 83) NEURO CDS , Pack Number CDS983981L ; 84) CRANI NEURO CDS , Pack Number CDS984172F ; 85) PUH NEURO EEA CDS , Pack Number CDS984297G ; 86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ; 87) ME

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJG·April 8, 2024

    Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ59632F; 42) CATH LAB PACK WITH NAMIC, Model Number: DYNJ60853D; 43) ANGIO PACK ALEX, Model Number: DYNJ63539C; 44) ANGIOGRAPHY CV RAD PACK, Model Number: DYNJ64936B; 45) CATH LAB PACK, Model Number: DYNJ65185D; 46) CATH PACK, Model Number: DYNJ65619A; 47) CATH I W SPLIT DRAPE PACK, Model Number: DYNJ66182; 48) CATH PACK SHD, Model Number: DYNJ68384B; 49) CATH LAB PACK, Model Number: DYNJ69094B; 50) CATH LAB ACCESSORIES, Model Number: DYNJ69213B; 51) REYES CATH PACK, Model Number: DYNJ69345A; 52) TMH ANGIOGRAPHY TRAY, Model Number: DYNJ80054A; 53) ANGIOGRAPHY TRAY, Model Number: DYNJ80156; 54) CATH PACK, Model Number: DYNJ80516C; 55) CATH PACK, Model Number: DYNJ80730; 56) ANGIO DRAPE PACK 2 WINDOW, Model Number: DYNJ81066B; 57) OR ANGIOGRAM PACK, Model Number: DYNJ81435F; 58) HEART CATH PACK, Model Number: DYNJ81527B; 59) HEART CATH PACK, Model Number: DYNJ83764D; 60) CATH LAB PACK, Model Number: DYNJ84048A; 61) ANGIO TRAY NO LIDO, Model Number: DYNJ85557B; 62) CARDIAC CATH PACK, Model Number: DYNJ85746B; 63) ANGIOGRAPHY PACK, Model Number: DYNJ86313; 64) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ86787; 65) CATH PACK, Model Number: DYNJ87098A; 66) CATH LAB TAVR PACK, Model Number: DYNJ88532; 67) SMT LEFT HEART CATH, Model Number: DYNJ89274; 68) VASCULAR CATH PACK, Model Number: DYNJ89352; 69) CATH LAB PACK, Model Number: DYNJ89805; 70) CARDIAC CATH MERCY WASHINGTON, Model Number: DYNJ89934; 71) ANGIO, Model Number: DYNJ900278G; 72) TAVR ICC VER. F, Model Number: DYNJ904401F; 73) TAVR, Model Number: DYNJ908646C; 74) LHK-UPMC CHILDRENS MAIN OR 2, Model Number: NAM0009; 75) KIT ANGIO CSTM-EVERGREEN, Model Number: NAM0020; 76) GP-CARDIAC CATH PACK-LF, Model Number: PHS397170009D; 77) LEFT HEART KIT - MARION, Model Number: VASC1073A; 78) RHK - VAMC RICHMOND, Model Number: VASC1185B; 79) LHK-MEADOWVIEW REG, Model Number: VASC1263; 80) LHK - BSC 3V ON S10RA, Model Number: VASC1269; 81) LHK - BSC 3V ON S10MLL, Model Number: VASC1270; 82

    FDA Recall
    Open, Classified ·Product code OES·February 25, 2026

    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

    FDA Recall
    Terminated ·Bien Air Dental SA Langgasse 60 Biel/bienne Switzerland·Product code EGS·August 27, 2015

    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JSS·May 21, 2014

    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JSI·March 28, 2016

    ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018

    ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011

    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011

    BD AffirM VPIII Microbial Identification Test

    FDA Recall
    Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code MLA·August 27, 2015