BEUDAMED
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    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

    FDA Enforcement
    Class II ·Terminated·Cardio Medical Products·July 17, 2013

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

    FDA Recall
    Terminated ·Cardio Medical Products·Product code LDD·April 26, 2013

    CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

    FDA Enforcement
    Class III ·Terminated·Cardiovascular Systems, Inc.·March 5, 2014

    Blake Cardio Connector 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code KOG·March 24, 2011

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Recall
    Terminated ·POM Medical LLC·Product code BYG·July 11, 2018

    Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. MAJOR PACK

    FDA Recall
    Terminated ·Windstone Medical, Inc.·March 25, 2003

    The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.

    FDA Recall
    Terminated ·Scion Cardio-Vascular, Inc.·Product code FGO·June 30, 2003

    Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT 15" X 20" L/F ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF ( 1) MAYO TRAY LARGE (8) DRAPE UTILITY WfTAPE LIF (1 ) TABLE COVER REINFORCED 44" X 78" LIF (2) GOWN SURG. SMS POLY-REINF BREATHABLE AAMI IV X-LARGE T/WRAP ( 1) DRAPE SPLIT CARDIO W/CLEAR ANEST. SC STD SMS ( 1) SHEET SPLIT BILATERAL 84" X 80" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OFA·May 20, 2014

    J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code KOG·March 24, 2011

    J-Vac Drain Adaptor Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code KOG·March 24, 2011

    Blake Silicone Drain, 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code KOG·March 24, 2011

    CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

    FDA Recall
    Terminated ·Cardiovascular Systems, Inc.·Product code MCX·January 27, 2014

    Blake Silicone Drain Kit Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code KOG·March 24, 2011

    SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST

    FDA Recall
    Terminated ·Scion Cardio-Vascular, Inc.·Product code FGO·May 23, 2003

    ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed; ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728; ACUSON Antares PE 4.0 & 5.0: 10032746, 10037591, 10038202, 10040729; SONOLINE Antares 4.0 & 5.0: 05936518, 08653771, 10037593; Antares Cardio Options: 10036613, 10036588, 10036585, 10436250; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The ACUSON Antare is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging, or 3D/4D imaging on a FPD display. The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc., Mountain View, CA 1230 Shorebird Way P.O. Box 7393 Mountain View CA 94043·Product code IYN·August 17, 2010

    ACUSON S2000 ultrasound systems (all versions) with cardiovascular options installed; ACUSON S2000: 10041461; S2000 Cardio Option: 10041853; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc., Mountain View, CA 1230 Shorebird Way P.O. Box 7393 Mountain View CA 94043·Product code IYO·August 17, 2010

    OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE (1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE (4) TOWELS CLOTH HUCK WHITE (2) STOCKINETTE IMPERVIOUS 14" X 48" LIF (30) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 54" X 54" (3) LITES GLOVE LIF OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKB CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH (2) PENCIL CAUTERY ROCKER SWITCH LIF (3) TUBE SUCTION CONNECT W X 12' LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE (2) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) BANDAGE ELASTIC 6" X 5yds LIF (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) NEEDLE HYPODERMIC 27G X %" ST. (1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz. (4) FEEDING TUBE 8FR, 15" LONG (2) BULB SYRINGE 60cc (1) TRAY PLATFORM LARGE (1) SKIN MARKER WITH RULER (1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54" X 54" UF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEEL OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKC CONTENTS: (9) TOWELS ABSORBENT 15" X 20" UF (6) GOWN FAB REINFORCED SONTARA X-LARGE (1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill (1) TABLE COVER REINFORCED 44" X 78" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OFA·May 20, 2014

    Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.

    FDA Recall
    Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

    Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.

    FDA Recall
    Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017