BEUDAMED
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    IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003

    The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing. Contents: Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. Manufactured For: NOVOMEDICUS, LLC P.O. Box 2105 Nokomis, FL 34274. Used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.

    FDA Recall
    Terminated ·Novomedicus Llc·Product code FTL·June 22, 2011

    The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only. Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. 2. 60cm x 85 cm Steri Drape 3. Drain with Connector 4. 4 x Gauze Rolls Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. Used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.

    FDA Recall
    Terminated ·Novomedicus Llc·Product code FTL·June 22, 2011

    BD Bactec Blood Culture Procedural Tray, Cat. Number 442805 Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 Used in conjunction with the blood collection system.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JGE·April 22, 2011

    BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code KST·April 22, 2011

    iSert Intraocular Lens (Model PC-60AD)

    FDA Recall
    Terminated ·Hoya Surgical Optics, Inc.·Product code HQL·June 17, 2011

    Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

    FDA Recall
    Terminated ·Penlon, Ltd. Abingdon Science Park Barton Lane Abingdon United Kingdom·Product code BSZ·November 29, 2011

    Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.

    FDA Recall
    Terminated ·Maquet Inc.·Product code CBK·December 22, 2011

    Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code KKX·June 6, 2011

    eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia.

    FDA Recall
    Terminated ·eSwallow USA LLC·Product code IPF·June 22, 2011

    Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBG·February 22, 2011

    Servo-s ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.

    FDA Recall
    Terminated ·Maquet Inc.·Product code CBK·December 22, 2011

    ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma.

    FDA Recall
    Terminated ·Phadia US Inc·Product code MVU·January 3, 2012

    Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution. The probe, is attached to the Imaging Console, and is used to direct light to and from the patient tissue. A small electromechanical scanning mechanism in the probe moves the optical beam laterally across the tissue surface while simultaneously acquiring in-depth backscattering profile at each lateral position. The probe is not labeled or sold as sterile.

    FDA Recall
    Terminated ·Imalux Corporation·Product code NQQ·December 22, 2011

    Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE), L7901 series, and L8031 series (100kV type MICROFOCUS x-ray source

    FDA Recall
    Terminated ·Hamamatsu Corporation·Product code RBS·March 30, 2011

    Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBG·February 22, 2011

    2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·February 25, 2011

    Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves

    FDA Recall
    Terminated ·Adenna Inc·Product code LYY·December 22, 2011

    Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code KOG·December 22, 2011

    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HRS·August 22, 2011