BEUDAMED
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    Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT

    FDA Recall
    Terminated ·Covidien LLC·Product code FSY·April 16, 2015

    Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·June 14, 2017

    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code GDR·May 11, 2017

    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.

    FDA Enforcement
    Class II ·Terminated·Baylis Medical Company Inc.·March 6, 2013

    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.

    FDA Recall
    Terminated ·Baylis Medical Company Inc. 5160 Explorer Drive #33 Mississauga Canada Ontario·Product code GXI·October 4, 2012

    First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·October 29, 2010

    First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B

    FDA Recall
    Terminated ·Ameditech Inc·Product code LDJ·August 18, 2020

    Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·November 19, 2014

    Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·November 19, 2014

    Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75

    FDA Recall
    Terminated ·Edwards Lifesciences Technology SARL·Product code DYG·November 27, 2006

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz L/F (1) SOLUTION SURGICAL DURAPREP 26ML UF (3) DRAPE UTILITY WITH TAPE UF (3) TOWEL CLAMP (2) TOWELS ABSORBENT 15" X 20" UF (1) NEEDLE 18G X 2% AMC/4 (1) FEMORAL ANGlO DRAPE WITH POUCH UF (1) BAND BAG RUBBAND & TAPE UF (1) CUP DENTURE WITH LID (30) GAUZE SPONGE 4" X 4" 12PL Y (2) TIP ASBORBENT APPLICATOR STICK SPONGE (1) SCALPEL WITH HANDLE #11 (1) STOPCOCK 3 WAY (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP ( 1) GUIDEWIRE .035" X 150cm MOVABLE (2) BAND BAG RUBBAND & TAPE L/F (2) DENTURE CUP 8oz. WITH LID ( 1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF ( 1) NEEDLE HYPODERMIC 18G X 1 % ( 1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (4) DRAPE UTILITY WITH TAPE L/F (2) SOLUTION SURGICAL DURAREP 6ml L/F (2) TOWEL CLAMP (1) NEEDLE 18G X 2% AMC/4 (4) TOWELS CLOTH HUCK BLUE ( 1) UTILITY BOWL 16oz. LIF ( 1) SCALPEL WITH HANDLE # 11 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014