BEUDAMED
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    Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 611005828 MODULAR CUP 10 DEGREE LIN 611005832 MODULAR CUP 10 DEGREE LIN 611006028 MODULAR CUP 10 DEGREE LIN 611006032 MODULAR CUP 10 DEGREE LIN 611006228 MODULAR CUP 10 DEGREE LIN 611006232 MODULAR CUP 10 DEGREE LIN 611006428 MODULAR CUP 10 DEGREE LIN 611006432 MODULAR CUP 10 DEGREE LIN 611006628 MODULAR CUP 10 DEGREE LIN 611006832 MODULAR CUP 10 DEGREE LIN 611007028 MODULAR CUP 10 DEGREE LIN 612004626 MODULAR CUP 20 DEGREE LIN 612004628 MODULAR CUP 20 DEGREE LIN 612004828 MODULAR CUP 20 DEGREE LIN 612004832 MODULAR CUP 20 DEGREE LIN 612005028 MODULAR CUP 20 DEGREE LIN 612005032 MODULAR CUP 20 DEGREE LIN 612005628 MODULAR CUP 20 DEGREE LIN 612005828 MODULAR CUP 20 DEGREE LIN 612005832 MODULAR CUP 20 DEGREE LIN 612006028 MODULAR CUP 20 DEGREE LIN 612006032 MODULAR CUP 20 DEGREE LIN 610504428 MODULAR CUP NEUTRAL LINER 610504832 MODULAR CUP NEUTRAL LINER 610505028 MODULAR CUP NEUTRAL LINER 610505032 MODULAR CUP NEUTRAL LINER 610505632 MODULAR CUP NEUTRAL LINER 610505832 MODULAR CUP NEUTRAL LINER 610506032 MODULAR CUP NEUTRAL LINER 610506232 MODULAR CUP NEUTRAL LINER For use in total hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 611005828 MODULAR CUP 10 DEGREE LIN 611005832 MODULAR CUP 10 DEGREE LIN 611006028 MODULAR CUP 10 DEGREE LIN 611006032 MODULAR CUP 10 DEGREE LIN 611006228 MODULAR CUP 10 DEGREE LIN 611006232 MODULAR CUP 10 DEGREE LIN 611006428 MODULAR CUP 10 DEGREE LIN 611006432 MODULAR CUP 10 DEGREE LIN 611006628 MODULAR CUP 10 DEGREE LIN 611006832 MODULAR CUP 10 DEGREE LIN 611007028 MODULAR CUP 10 DEGREE LIN 612004626 MODULAR CUP 20 DEGREE LIN 612004628 MODULAR CUP 20 DEGREE LIN 612004828 MODULAR CUP 20 DEGREE LIN 612004832 MODULAR CUP 20 DEGREE LIN 612005028 MODULAR CUP 20 DEGREE LIN 612005032 MODULAR CUP 20 DEGREE LIN 612005628 MODULAR CUP 20 DEGREE LIN 612005828 MODULAR CUP 20 DEGREE LIN 612005832 MODULAR CUP 20 DEGREE LIN 612006028 MODULAR CUP 20 DEGREE LIN 612006032 MODULAR CUP 20 DEGREE LIN 610504428 MODULAR CUP NEUTRAL LINER 610504832 MODULAR CUP NEUTRAL LINER 610505028 MODULAR CUP NEUTRAL LINER 610505032 MODULAR CUP NEUTRAL LINER 610505632 MODULAR CUP NEUTRAL LINER 610505832 MODULAR CUP NEUTRAL LINER 610506032 MODULAR CUP NEUTRAL LINER 610506232 MODULAR CUP NEUTRAL LINER For use in total hip arthroplasty

    FDA Recall
    Terminated ·Product code LPH·January 11, 2016

    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 4, 2015

    MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LPH·October 11, 2013

    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·August 23, 2011

    Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer

    FDA Enforcement
    Class III ·Terminated·Lin-Zhi International Inc·April 2, 2014

    Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DJG·February 18, 2014

    Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.

    FDA Enforcement
    Class III ·Terminated·Lin-Zhi International Inc·December 4, 2013

    EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020

    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code JJW·February 6, 2014

    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DLJ·February 6, 2014

    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Enforcement
    Class II ·Terminated·Lin-Zhi International Inc·March 19, 2014

    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Enforcement
    Class II ·Terminated·Lin-Zhi International Inc·March 19, 2014

    Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing Lin-Zhi International, Inc.' 670 Almanor Ave. Sunnyvale, CA 94085.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·October 11, 2011

    Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·February 7, 2008

    Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIC·January 11, 2019

    Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label.

    FDA Recall
    Terminated ·Western a Scott Fetzer Co·Product code BZD·October 2, 2003