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    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·March 4, 2022

    Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK

    FDA Recall
    Open, Classified ·Product code GAT·December 2, 2022

    Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863035-51 TICRON 2-0 BLU 105CM CV305DA 88863047-41 TICRON* 3-0 BLU 45CM C13X36 88863048-51 TICRON* 2-0 BLU 75CM C13X36 88863050-61 TICRON* 0 BLU 75CM C14 X36 88863054-51 TICRON* 2-0 BLU 75CM C17X36 88863056-89 TICRON* 5 BLU 45CM GS18X12 88863059-53 TICRON* 2-0 BLU 45CM P24X12 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863088-51 TICRON* 2-0 BLU 75CM Y5X36 88863090-51 TICRON 2-0 BLU 75CM GS21X36 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863109-43 TICRON* 3-0 BLU 45CM P22X12 88863111-79 TICRON* 5 BLU 75CM HGS21X36 88863119-61 TICRON* 0 BLU 75CM KV34X36 88863154-09 TICRON* 4 BLU 75CM GS11X36 88863159-31 TICRON* 4-0 BLU 90CM KV5DA 88863160-41 TICRON* 3-0 BLU 90CM Y31DA 88863163-61 TICRON* 0 BLU 75CM SC1 X36 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-41 TICRON* 3-0 BLU 75CM CV331 88863212-51 TICRON* 2-0 BLU 90CM Y5DA7P 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863280-21 TICRON* 5-0 BLU 75CM CV301DA 88863280-31 TICRON* 4-0 BLU 75CM CV301DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 88863369-31 TICRON* 4-0 BLU 90CM CV316DA 88863393-51 TICRON* 2-0 BLU 90CM CV300DA CD-3123K TICRON* 5-0 WHI 45CM SS24 DA

    FDA Recall
    Open, Classified ·Product code GAT·December 2, 2022

    Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA

    FDA Recall
    Open, Classified ·Product code GAT·December 2, 2022

    Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6 8886 4410-13 NOVAFIL 6-0 BLU 45CM P10 8886 4410-03 NOVAFIL 7-0 BLU 45CM P10 8886 4422-43 NOVAFIL 3-0 BLU 45CM C14 8886 4424-51 NOVAFIL 2-0 BLU 75CM C16 8886 4450-41 NOVAFIL 3-0 BLU 75CM V26 8886 4452-51 NOVAFIL 2-0 BLU 75CM V20 8886 4459-61 NOVAFIL 0 BLU 75CM GS22 8886 4470-81 NOVAFIL* 2 BLU 150CM GS26 8886 4582-53 NOVAFIL* 2-0 BLU 75CM P14 SPB-1213G NOVAFIL* 6-0 BLU 45CM P13X12 SPB-1233G NOVAFIL* 4-0 BLU 45CM P13X12 SPB-1623G NOVAFIL* 5-0 BLU 45CM P12X12 SPB-5142G NOVAFIL* 5-0 BLU 45CM P11X12 SPB-5143G NOVAFIL* 4-0 BLU 45CM P11X12 SUT SPB-5223G NOVAFIL 5-0 BLU 45CM P13 SPB-5433G NOVAFIL* 4-0 CLR 45CM P24X12 SPB-5633G NOVAFIL* 4-0 BLU 45CM P12X12

    FDA Recall
    Open, Classified ·Product code GAT·December 2, 2022

    OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

    FDA Recall
    Open, Classified ·SIMPLIVIA HEALTHCARE LTD. NORTH IND. ZONE, (MIGADA PLANT) NORTH IND. ZONE PoBOX·Product code ONB·March 8, 2022

    Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

    FDA Recall
    Open, Classified ·Draeger Medical Systems, Inc.·Product code MHX·May 13, 2024

    Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·February 8, 2019

    Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·February 8, 2019

    Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·October 9, 2019

    Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code CBK·September 10, 2021

    Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code NGT·August 19, 2021

    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code CBK·September 10, 2021

    The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·September 13, 2019

    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code BSZ·October 15, 2024

    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

    BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code PSZ·January 5, 2022

    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code BSZ·October 15, 2024

    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code BSZ·September 9, 2025

    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code BSZ·September 9, 2025