BEUDAMED
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    YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.

    FDA Recall
    Open, Classified ·Young Dental Mfg Co I LLC·Product code JOJ·December 29, 2021

    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

    FDA Recall
    Terminated ·InfuTronix LLC·Product code FRN·May 28, 2019

    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OEQ·July 24, 2024

    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FRN·July 6, 2011

    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

    FDA Recall
    Terminated ·Ebi, Llc·Product code MAX·April 9, 2013

    Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code FJI·February 26, 2016

    Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019

    Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019

    CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019

    Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

    FDA Recall
    Open, Classified ·Allergan Sales, LLC·Product code KDD·March 14, 2024

    DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Recall
    Terminated ·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021

    DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Recall
    Terminated ·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021

    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Recall
    Terminated ·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021

    DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Recall
    Terminated ·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021

    Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations

    FDA Recall
    Terminated ·Apogee Medical, Inc·Product code OHR·March 24, 2011

    Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.

    FDA Recall
    Terminated ·Ohio Medical Corporation·Product code BTA·August 14, 2018

    Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020

    Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020

    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020

    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 7, 2020