BEUDAMED
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    Filters Classification: Class Ii ×

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·August 14, 2013

    Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 0752-74 CATARACT V A MED CTR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 11401-13 CATARACT SUTTER SOLANO MED CTR 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR 11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE 12185-14 CATARACT LASERVUE EYE CENTER 12213-12 CATARACT TULSA SPINE AND SPECIALTY 12213-13 CATARACT TULSA SPINE AND SPECIALTY 12213-15 CATARACT TULSA SPINE AND SPECIALTY 12213-16 CATARACT TULSA SPINE AND SPECIALTY 12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR 12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP 12942-18 CONRAD PHYSICIANS MEDICAL CENTER 12942-19 CONRAD PHYSICIANS MEDICAL CENTER 13567-10 OPHTHALMIC PHYSICIANS SURG CTR 13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT 13970-11 CATARACT GWINNETT CTR OUTPT SURG 13970-12 CATARACT GWINNETT CTR OUTPT SURG 14389-08 INFINITI STAMFORD SURGICAL CENTER 14408-12 E-Z PACK QUEEN OF THE VALLEY 14408-13 E-Z PACK QUEEN OF THE VALLEY 14533-18 OPHTHALMIC UOFL HOSPITAL 15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR 15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC 15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER 15502-10 DR NEWCOMB LEXINGTON CLINIC 15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR 15678-13 DR RAUEN CLARKE COUNTY HOSPITAL 15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC 16001-12 DR YONKER/BESCAK CESC 16001-13 DR YONKER/BESCAK CESC 16013-12 DR MCDONALD NORTH FL SURG PAVILION 16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT 16177-08 OPHTHALMIC DENVER EYE SURG CTR 16204-13 CATARACT V A HOSPITAL 16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA 16452-06 RAECKER PACK GREATER COMMUNITY HOSP 16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ 16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16798-08 CATARACT HAUSER ROSS EYE INSTITUTE 16820-06 PHACO LONE PEAK SURGERY CENTER 17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU 17201-18 SILVERA VALLEY SURGERY CENTER 17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP 17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR 17361-08 MICRO PAK CARLE FOUNDATION HOSP 17382-05 CATARACT BILLINGS VA MEDICAL CENTE 17382-07 CATARACT BILLINGS VA MEDICAL CENTE 17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC 17520-05 DR GROSS CHARLESTON SURGERY CTR 17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O 17529-09 CPK0927 AESC VANTAGE OUTSOURCING 17541-07 HAIDER DUPONT SURG CTR 17541-08 HAIDER DUPONT SURG CTR 17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA 17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER 17653-06 DR HUNT CHARLESTON AREA MED CTR 17671-06 CATARACT EDMONDS CENTER FOR OUTPAT 17671-07 CATARACT EDMONDS CENTER FOR OUTPAT 17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP 17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL 17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR 17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER 17987-05 OPHTHALMIC SEATTLE SURGERY CENTER 18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY 18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C 18208-09 CATARACT SUTTER FAIRFIELD SURG CTR 18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18384-04 DR BURKS SPRINGHILL SURGERY CENTER 18401-04 MCGRAW SIGHTPATH MEDICAL 18406-03 DR KUCHINKA HAYWARD AREA HOSP 18427-07 CATARACT V A HOSPITAL 18427-08 CATARACT V A HOSPITAL 18431-06 VISION EYE SC VISION EYE SURGERY CENTER 18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT 18550-04 DR HU TORRES CAT & LSR CNTRL 18555-04 DR WU - CENTURION CAT & LSR CNTRL 18636-10 CATARACT BONNER GENERAL HOSPITAL

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LLC·May 1, 2024

    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·July 17, 2024

    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

    Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pack Number DYNJ63532; 7) BASIC PACK, Pack Number DYNJ81702; 8) BASIC PACK, Pack Number DYNJ36595D; 9) BASIC PACK, Pack Number DYNJ69250A; 10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C; 11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A; 12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A; 13) CABG PACK, Pack Number DYNJ20114Q; 14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L; 15) CHEST PACK SC-LF, Pack Number DYNJ38051F; 16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B; 17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B; 18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C; 19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B; 20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385; 21) CT BASIC PACK, Pack Number DYNJ51617A; 22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I; 23) CYSTO, Pack Number DYNJ24351D; 24) CYSTO PACK, Pack Number DYNJ62359A; 25) DAVINCI PACK, Pack Number DYNJ04113C; 26) DUPYTRENS PACK, Pack Number DYNJ60496; 27) EH PACEMAKER PACK, Pack Number DYNJ55734C; 28) EVLT PACK, Pack Number DYNJ45997C; 29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G; 30) GENERAL BASIC PACK, Pack Number DYNJ82039; 31) GENERAL PURPOSE CV, Pack Number DYNJ904395F; 32) GENERAL UTILITY PACK, Pack Number DYNJ45093B; 33) HP DEVICE-LF, Pack Number DYNJ62255A; 34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B; 35) IR PACK, Pack Number DYNJ32080L; 36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857; 37) IR TABLE PACK II, Pack Number DYNJ56298B; 38) JVL-PACK TUNNELED, Pack Number DYNJ66065; 39) LITHOTOMY PACK, Pack Number DYNJ66490B; 40) LITHOTOMY PACK, Pack Number DYNJ65380A; 41) LOOP RECORDER PACK, Pack Number DYNJ53221B; 42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A; 43) MAJOR BASIN PACK, Pack Number DYNJ67484A; 44) MAJOR PACK, Pack Number DYNJ51996; 45) MAJOR PACK-LF, Pack Number DYNJ24599I; 46) MINI PACK, Pack Number DYNJ52305D; 47) MINI SET UP KIT, Pack Number DYNJ81562; 48) MINOR BASIN, Pack Number DYNJ43021B; 49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286; 50) MINOR PACK-LF, Pack Number DYNJ0551383P; 51) MINOR PK-LF, Pack Number DYNJ21408D; 52) MINOR WAKEFIELD, Pack Number DYNJ58872A; 53) MYELOGRAM TRAY, Pack Number DYNDH1775A; 54) OB PACK, Pack Number DYNJ32216B; 55) OPEN STERILE PACK, Pack Number DYNJ62104A; 56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B; 57) PACK URO-BASIC, Pack Number DYNJ38246A; 58) PACK,LTD BODY SSP, Pack Number DYNJ65488B; 59) PARACENTESIS, Pack Number DYNJ44505B; 60) PBMS NECK PACK-LF, Pack Number DYNJ64961A; 61) PEDI MAJOR PACK, Pack Number DYNJ40062K; 62) PEDI PK-LF, Pack Number DYNJ21240J; 63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B; 64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B; 65) PK, GEN-MINOR, Pack Number DYNJ59461C; 66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B; 67) PK, URO-CYSTO-MH, Pack Number DYNJ62501; 68) PK-GEN-BASIC, Pack Number DYNJ42382B; 69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B; 70) PODIATRY PACK, Pack Number DYNJ37297D; 71) PST PACK, Pack Number DYNJ62666; 72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J; 73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A; 74) SHUNT PACK-LF, Pack Number PHS967363W; 75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242; 76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X; 77) STANDARD ICL PACK-LF, Pack Number PHS895675B; 78) T & A PK-LF, Pack Number DYNJT2408C; 79) THORACIC PACK SHD, Pack Number DYNJ68416C; 80) TONSIL PACK-LF, Pack Number DYNJ0553334I; 81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I; 82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M; 83) VASECTOMY PACK, Pack Number DYNJ65326; 84) VASECTOMY PACK,

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025