72 results
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Sources: EU EUDAMED, US FDA
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Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090
FDA Recall
Terminated
·Manan Medical Products, Inc.·Product code KXK·May 3, 2005
BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons.
FDA Recall
Terminated
·Bard Brachytherapy, Inc.·Product code KXK·April 10, 2018
PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.
FDA Recall
Terminated
·Theragenics Corporation·Product code KXK·May 16, 2005
M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.
FDA Recall
Terminated
·Source Production & Equipment Inc·Product code KXK·March 3, 2008
VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code KXK·January 25, 2012
I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code KXK·December 9, 2016
Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000. RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy.
FDA Recall
Terminated
·Medi-Physics Inc. dba GE Healthcare·Product code KXK·September 20, 2011
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 1, 2022
Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.
FDA Recall
Terminated
·Zimmer, Inc.·Product code NDG·August 28, 2013
Kit BD Max ExK TNA 2; Catalog # 442825
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 1 USA; Catalog # 442817
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 2 USA; Catalog # 442819
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JJH·July 17, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK TNA 2; Catalog # 442825
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EQN·December 6, 2019
Kit BD Max ExK DNA 1 USA; Catalog # 442817
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 USA; Catalog # 442819
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019