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    Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·July 22, 2014

    Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 1, 2022

    IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).

    FDA Recall
    Terminated ·Diametrics Medical, Inc.·Product code JJE·July 14, 2003

    Case Label: REORDER NO. 7501 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7501 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Urethral Catheter Tray With Plastic Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad. Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REORDER NO. 7500 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/o Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7500 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Urethral Catheter Tray Without Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REORDER NO. 7502 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter includes BZK Swabsticks Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7502 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Disposable Urethral Catheterization Tray With 14 French Red Rubber Catheter Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 14 French Red Rubber Catheter Gloves Fenestrated Drape BZK Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REORDER NO. 7504 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7504 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Foley Catheter Tray With 30 mL Prefilled Syringe Including BZK Swabsticks nurse assist incorporated A6005, R1 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad Vinyl Gloves Fenestrated Drape Lube Jelly 1200 mL Graduated Tray 30 mL Prefilled Syringe BZK Swabsticks Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REORDER NO. 7503 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7503 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Foley Catheter Tray With 10 mL Prefilled Syringe Including BZK Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad Vinyl Gloves Fenestrated Drape Lube Jelly 1200 mL Graduated Tray 10 mL Prefilled Syringe BZK Swabsticks Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REF UT8155 Urethal Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast REF: UT8155 Urethral Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr red rubber latex catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: REF UT7015 Catheter Insertion Tray 10cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT7015 Catheter Insertion Tray 10 cc Pre-Filled Syringe with BZK Swabs contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 10 cc pre-filled syringe Swabsticks (3) BZK solution For Rx Only. Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    Case Label: REF UT7035 Catheter Insertion Tray 30cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT7035 Catheter Insertion Tray 30 cc Pre-Filled Syringe with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 30 cc pre-filled syringe Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 3, 2014

    Case Label: REF UT 8145 Urethral Insertion Tray 14Fr Nelaton PVC Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT8145 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with BZK Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr. PVC Nelaton catheter Swabsticks (3) BZK solution For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays. Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    NGK Stem Ext 24 x 245mm

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    NGK Stem Ext 24 x 245mm

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·November 5, 2013

    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended for the quantitative measurement of sodium, potassium, chloride and total carbon dioxide in human serum and heparinized plasma. They are also intended for the quantitative measurement of Na+, K+ and Cl- in urine.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CEM·February 24, 2015

    Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012

    Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012

    Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012

    Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012