BEUDAMED
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    Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 21, 2017

    ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 29, 2014

    (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 13, 2016

    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·April 11, 2018

    Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·April 11, 2018

    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-KH; (3) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-LC; (4) PSI Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-PHP; (5) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09907-LGH1; (6) Arrow PSI Kit, Part Number: CDC-09803-1A; (7) Arrow PSI Kit, Part Number: CDC-09903-1A

    FDA Recall
    Terminated ·Arrow International Inc·Product code DYB·December 22, 2017

    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD

    FDA Recall
    Terminated ·Arrow International Inc·Product code DYB·December 22, 2017

    ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

    FDA Enforcement
    Class II ·Terminated·ARROW INTERNATIONAL Inc.·October 26, 2022

    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.

    FDA Recall
    Terminated ·H & H Associates·Product code BSK·August 27, 2013

    BD, Francisella tularensis Antigen

    FDA Recall
    Terminated ·BD Diagnostic Systems·Product code GSK·October 20, 2004

    Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DSK·May 4, 2012

    Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·May 3, 2017

    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·April 11, 2018

    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Arrow Maximal Barrier Drape ASK-00002-1A

    FDA Recall
    Terminated ·Arrow International Inc·Product code KKX·December 20, 2019

    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·January 28, 2015

    Maximal Barrier Drape; Product Codes: ASK-00001-1A

    FDA Recall
    Terminated ·Arrow International Inc·Product code KKX·April 11, 2018