BEUDAMED
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    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

    FDA Recall
    Terminated ·TERRIFIC CARE LLC 61 Willet St Bldg A-1, Fl 2 Passaic NJ 07055-1971·Product code GJS·December 20, 2018

    CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code GJS·December 2, 2020

    CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code GJS·May 16, 2013

    Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

    FDA Recall
    Terminated ·Dexcom Inc·Product code MDS·February 3, 2020

    Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

    FDA Recall
    Terminated ·Dexcom Inc·Product code PQF·February 3, 2020

    Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

    FDA Recall
    Terminated ·Dexcom Inc·Product code QBJ·February 3, 2020

    ST AIA-PACK PROG III, Progesterone III Assay, Part Number: 025240

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JLS·February 13, 2018

    ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JLS·February 13, 2018

    Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);

    FDA Recall
    Open, Classified ·MicroAire Surgical Instruments, LLC·Product code EMF·May 7, 2025

    STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·September 18, 2013

    0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240

    FDA Recall
    Open, Classified ·Nurse Assist, LLC·Product code NGT·November 6, 2023

    COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GGK·December 28, 2010

    Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010

    FDA Recall
    Open, Classified ·Nurse Assist, LLC·Product code EZL·November 6, 2023

    Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007

    FDA Recall
    Open, Classified ·Nurse Assist, LLC·Product code FRO·November 6, 2023

    0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR

    FDA Recall
    Open, Classified ·Nurse Assist, LLC·Product code NGT·November 6, 2023

    Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021

    Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021

    Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021

    Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021

    Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021