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    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·May 25, 2011

    Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;

    FDA Recall
    Open, Classified ·Telcare, LLC·Product code NBW·January 30, 2025

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Recall
    Terminated ·SA3, LLC·Product code OLR·February 21, 2022

    Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Test strips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code NBW·January 29, 2004

    a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FRO·May 25, 2022

    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

    FDA Recall
    Terminated ·Kim's Trading Inc·Product code LPM·May 17, 2010

    CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

    FDA Recall
    Terminated ·LMS Medical Systems Ltd·Product code HGM·January 11, 2005

    Philips Avalon Fetal Monitor FM30; Model Number: M2703A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·May 12, 2009

    Philips Avalon Fetal Monitor FM20; Model Number: M2702A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·May 12, 2009

    Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code HGM·October 24, 2025

    GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended for use as a clinical data management system.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008

    HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems.

    FDA Recall
    Terminated ·EUROTROL INC·Product code GGM·October 18, 2018

    Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019

    Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code HGM·May 26, 2026