ANXIETY (aconitum napellus, arsenicum album, belladonna, calcarea carbonica, carcinosin, causticum, gelsemium sempervirens, lachesis mutus, mercurius vivus, nitricum acidum, phosphorus, rhus tox) spray [Energique, Inc.]
Updated Date: Fri, 23 Jul 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 23, 2021 Category: Drugs & Pharmacology Source Type: alerts

Philips North America Llc - Class 2 Recall
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 1, 2021 Category: Medical Devices Source Type: alerts

Elekta, Inc. - MOSAIQ - Class 2 Recall
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2021 Category: Medical Devices Source Type: alerts

LYMPH III (echinacea (angustifolia), boldo, phytolacca decandra, pinus sylvestris, thyroidinum (suis), germanium sesquioxide, arnica montana, calcarea iodata, hamamelis virginiana, hepar sulphuris calcareum, adenosinum triphosphoricum dinatrum, ubidecarenonum, naja tripudians, calcarea phosphorica, influenzinum (2020-2021), natrum sulphuricum, pyrogenium, sulphur, carcinosin) liquid [BioActive Nutritional, Inc.]
Updated Date: Fri, 21 May 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 21, 2021 Category: Drugs & Pharmacology Source Type: alerts

W.L. Gore & Associates, Inc. - GORE VIBIL Biliary Endoprosthesis - Class 2 Recall
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2021 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Onocology Kit - Class 2 Recall
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2021 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - ChemoLock IV Admin Set - Class 2 Recall
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2021 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - ICU ChemoClave System - Class 2 Recall
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2021 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Onocology Kit - Class 2 Recall
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2021 Category: Medical Devices Source Type: alerts

MERCI HANDY SANCTUARY HAND SANITIZER CANCER (alcohol) gel [MERCI HANDY CORPORATION]
Updated Date: Mon, 03 May 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 3, 2021 Category: Drugs & Pharmacology Source Type: alerts

FLUDEOXYGLUCOSE F 18 injection [The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute]
Updated Date: Mon, 19 Apr 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 19, 2021 Category: Drugs & Pharmacology Source Type: alerts

FLUDEOXYGLUCOSE F-18 injection [Barbara Ann Karmanos Cancer Hospital]
Updated Date: Mon, 05 Apr 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 5, 2021 Category: Drugs & Pharmacology Source Type: alerts

RAYSEARCH LABORATORIES AB - RayCare - Class 2 Recall
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2021 Category: Medical Devices Source Type: alerts

V HP (arsenicum album, belladonna, carcinosin, echinacea (angustifolia), eupatorium perfoliatum, gelsemium sempervirens, lycopodium clavatum, phosphoricum acidum, phosphorus, pyrogenium, rhus tox) liquid [Energique, Inc.]
Updated Date: Mon, 15 Mar 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 15, 2021 Category: Drugs & Pharmacology Source Type: alerts

VAXR HC (thuja occidentalis, mezereum, silicea, calcarea carbonica, morbillinum, parotidinum, pertussinum, rubella nosode, tetanus toxin, carcinosin, antimonium crudum, ledum palustre, thimerosal, poliomyelitis nosode) liquid [Deseret Biologicals, Inc.]
Updated Date: Thu, 11 Mar 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 11, 2021 Category: Drugs & Pharmacology Source Type: alerts

Qiagen Sciences LLC - therascreen PIK3CA RGQ PCR Kit - Class 2 Recall
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 30, 2021 Category: Medical Devices Source Type: alerts

WHOLE SYSTEM EEP (mercurius corrosivus,nux vomica,hyoscyaminum,carcinosinum,graphites,zincum metallicum,lilium tigrinum,cinchona officinalis,causticum,coffea cruda,belladonna,ignatia amara,scrophularia nodosa,spongia tosta ,ceanothus americanus,senna,hydrastis canadensis,condurango,chelidonium majus,pituitary gland, bos taurus,pancreas suis,lycopodium clavatum,berberis vulgaris,) liquid [White Manufacturing Inc. DBA Micro-West]
Updated Date: Mon, 25 Jan 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 25, 2021 Category: Drugs & Pharmacology Source Type: alerts

VAX REACTION (thuja occidentalis, mezereum, silicea, calcarea carbonica, morbillinum, parotidinum, pertussinum, poliomyelitis nosode, rubella nosode, tetanus toxin, carcinosin, antimonium crudum, ledum palustre, thimerosal, poliomyelitis nosode) liquid [Deseret Biologicals, Inc.]
Updated Date: Thu, 21 Jan 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 21, 2021 Category: Drugs & Pharmacology Source Type: alerts

GLUCOREG (ascorbicum acidum, pyridoxinum hydrochloricum, riboflavinum, sarcolacticum acidum, thiaminum hydrochloricum, dhea (dehydroepiandrosterone), phloridzinum, adenosinum triphosphoricum dinatrum, alpha-lipoicum acidum, citricum acidum, fumaricum acidum, nadidum, pantothenic acid, acetaldehyde, insulinum (suis), insulinum (human), hepar suis, pancreas suis, phloridzinum, baryta oxalica, alloxanum, berberis vulgaris, carcinosin, lycopodium clavatum, momordica balsamina, phosphoricum acidum, phosphorus,) liquid [Deseret Biologicals, Inc.]
Updated Date: Fri, 15 Jan 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 15, 2021 Category: Drugs & Pharmacology Source Type: alerts

ICU Medical, Inc. - ChemoLock Closed System Drug Transfer Device - Class 2 Recall
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext w/2 ChemoClave, Red Ring, BCV; 297cm Ext w/ChemoClave, REF: 011-CH3600; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext, w/2 ChemoClave, Red Ring, BCV; 597 cm Ext w/ChemoClave, REF: 011-CH3601; Kit, 2 5 Gang Stopcocks w/5 MicroClave Clear, Spiros; 2 Smallbore...
Source: Medical Device Recalls - December 24, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - ChemoClave Cytotoxic Medication Preparation and Delivery System - Class 2 Recall
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Drip Chamber, Clave, Bag Hanger, REF: CH3240; 18 IN (46 cm) Appx 2.9 ml, Add-On Set w/Spiros, Clave Spike, Clamp, ...
Source: Medical Device Recalls - December 24, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - ChemoLock Closed System Drug Transfer Device - Class 2 Recall
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3020; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, Drop-In Red Cap, REF: CL3028; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber...
Source: Medical Device Recalls - December 24, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - ChemoLock Closed System Drug Transfer Device - Class 2 Recall
3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL Syringe w/Spinning Spiros, Red Cap, REF: CH2060; 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CH3011; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Red Cap, Hanger, REF: CH3011-C; 40 IN (102 cm) App 4.8 ml, Admin Set, 20 Drop, 2 Spiros, ...
Source: Medical Device Recalls - December 24, 2020 Category: Medical Devices Source Type: alerts

FLUDEOXYGLUCOSE F-18 injection [Barbara Ann Karmanos Cancer Hospital]
Updated Date: Fri, 18 Dec 2020 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 18, 2020 Category: Drugs & Pharmacology Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation - Class 2 Recall
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 21, 2020 Category: Medical Devices Source Type: alerts

Shanghai United Imaging Healthcare Co., Ltd. - uMI 550 PET/CT System - Class 2 Recall
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - WallFlexTM Biliary RX Fully Covered Stent System RMV - Class 2 Recall
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayCare - Class 2 Recall
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2020 Category: Medical Devices Source Type: alerts

Shanghai United Imaging Healthcare Co., Ltd. - Positron Emission Tomography and Computed Tomography System - Class 2 Recall
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2020 Category: Medical Devices Source Type: alerts

Shanghai United Imaging Healthcare Co., Ltd. - uMI 550 - Class 2 Recall
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 14, 2020 Category: Medical Devices Source Type: alerts

Shanghai United Imaging Healthcare Co., Ltd. - uEXPLORER - Class 2 Recall
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 14, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 8B SP1 - Class 2 Recall
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 6 SP3 - Class 2 Recall
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation SP2 - Class 2 Recall
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 9B - Class 2 Recall
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 8A SP1 - Class 2 Recall
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 8B SP2 - Class 2 Recall
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 4.0, 5SP2 - Class 2 Recall
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 8B - Class 2 Recall
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 7 - Class 2 Recall
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 9B SP1 - Class 2 Recall
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 9A - Class 2 Recall
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 5SP3 - Class 2 Recall
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 8A - Class 2 Recall
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 6 SP1 - Class 2 Recall
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation 6 - Class 2 Recall
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts

Elekta, Inc. - Elekta Unity - Class 2 Recall
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2020 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Access GI Monitor - Class 2 Recall
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2020 Category: Medical Devices Source Type: alerts

Merit Medical Systems, Inc. - DFINE Vertebral Hydraulic Assemblies - Class 2 Recall
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2020 Category: Medical Devices Source Type: alerts

Merit Medical Systems, Inc. - DFINE Vertebral Assemblies - Class 2 Recall
DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2020 Category: Medical Devices Source Type: alerts