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    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018455, Size 5 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018480, Size 8, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018485, Size 8 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018465, Size 6 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018475, Size 7 1/2, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018470, Size 7, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code NPD·June 10, 2011

    Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·February 25, 2015

    HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: 1) Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. 2) Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. The HomeChoice APD system and HomeChoice Pro APD system are the same in operation, except for the Pro Card and modem features that are only available with the HomeChoice Pro APD system. The Pro Card feature stores prescription and therapy data. The data can be transferred between your cycler and your clinician. The two systems use the same disposable sets and solutions. They perform the same therapies the same way.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·October 6, 2014

    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FIK·April 3, 2014

    Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·June 29, 2015

    APD Drain Manifold

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·April 21, 2022

    Automated peritoneal dialysis (APD) cycler

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·February 16, 2016

    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock connector (e.g., Liberty cycler, Newton IQO cycler).

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code FKX·May 29, 2019

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001245260 VTCG/8/25 M001245270 VTCG/10/25 M001245280 VTCG/12/25 M001245290 VTCG/14/25 M001245300 VTCGK/8/25 M001245310 VTCGK/10/25 M001245320 VTCGK/12/25 M001245061 APD/LPG/6/25 (BX/5) M001245071 APDL/8.3/20 (BOX/5) M001245081 APD/LPG/10/25 (BX/5) M001245130 VSCD/LPG/12/25 M001245140 VSCD/LPG/14/25 Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·March 18, 2009

    Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FKX·November 15, 2023

    APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·March 16, 2011

    APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FKX·December 16, 2016