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    CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA 21-2111-0300-09_FUK CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO 21-2111-0300-09_KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA 21-2111-0300-09_OKA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA 21-2111-0300-09_OMI CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA 21-2111-0300-09_OSA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO 21-2111-0300-09_SAP CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO 21-2111-0300-09_TOK CADD_SOLIS_MODEL 2110_ENGLISH_1/EA 21-2111-0200-50JP CADD-Solis VIP CADD-SOLIS V4.2 LOAN FUK 21-2111-0402-09-FUK CADD-SOLIS V4.2 LOAN NAG 21-2111-0402-09-NAG CADD-SOLIS V4.2 LOAN OKA 21-2111-0402-09-OKA CADD-SOLIS V4.2 LOAN OSA 21-2111-0402-09-OSA CADD-SOLIS V4.2 LOAN SAI 21-2111-0402-09-SAI CADD-SOLIS V4.2 LOAN SAP 21-2111-0402-09-SAP CADD-SOLIS V4.2 LOAN TOKE 21-2111-0402-09-TOKE CADD-SOLIS V4.2 LOAN TOKW 21-2111-0402-09-TOKW CADD-SOLIS V4.2 LOAN YELLOW KYO 21-2112-0402-09-KYO CADD-SOLIS V4.2 LOAN YELLOW NAG 21-2112-0402-09-NAG CADD-SOLIS V4.2 LOAN YELLOW YOK 21-2112-0402-09-YOK CADD-SOLIS V4.2 LOAN YOK 21-2111-0402-09-YOK Number:21-2111-0403-02Part Type:List Number/Finished GoodLifecycle Phase:03-ReleasedDescription:PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, FRENCH, 1/EA 21-2111-0403-02 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, YELLOW, ENGLISH, 1/EA 21-2112-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA 21-2111-0300-00 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DANISH 1/EA 21-2111-0300-12 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DUTCH 1/EA 21-2111-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, FRENCH 1/EA 21-2111-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, GERMAN 1/EA 21-2111-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, ITALIAN 1/EA 21-2111-0300-07 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, JAPANESE 21-2111-0300-09JP PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, FRENCH 1/EA 21-2111-0300-232 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA 21-2111-0300-231 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, SWEDISH 1/EA 21-2111-0300-244 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA 21-2111-0300-50 Not PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, PORTUGUESE 1/EA 21-2111-0300-17 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SPANISH 1/EA 21-2111-0300-08 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SWEDISH 1/EA 21-2111-0300-14 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, DUTCH 1/EA 21-2112-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, GERMAN 1/EA 21-2112-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA 21-2112-0300-00 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, DANISH 1/EA 21-2101-0200-12 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, FRENCH 1/EA 21-2101-0200-02 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, GERMAN 1/EA 21-2101-0200-03 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, ITALIAN 1/EA 21-2101-02

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·April 10, 2025

    CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2112-0300-01; 5) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2111-0300-01; 6) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-51; 7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-51; 9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA, Model Number: 21-2111-0400-51; 11) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2111-0300-50; 12) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 13) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 14) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-78; 15) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 16) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2112-0300-00; 17) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-78; 18) PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN USE 1/EA, Model Number: 21-2101-249; 19) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-78; 20) PUMP KIT, CADD-SOLIS, YELLOW, MDL 2100 1/EA, Model Number: 21-2102-51; 21) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, NFHU, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-249; 22) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA, Model Number: 21-2111-0300-231; 23) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-78; 24) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0400-51; 25) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2112-0300-50; 26) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 27) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 28) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 29) PUMP, CADD-SOLIS, MODEL 2110, CE ENGLISH OUS 1/EA, Model Number: 21-2111-0100-50; 30) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 31) PUMP KIT, CADD-SOLIS HPCA, YELLOW KEYPAD, MODEL 2110, CE ENGLISH, OUS 1/EA, Model Number: 21-2112-0100-50; 32) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 33) PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA, Model Number: 21-2112-0400-01.

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·April 10, 2025

    3mensio Workstation (Vascular Fenestrated) software

    FDA Recall
    Open, Classified ·PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands·Product code LLZ·July 14, 2025

    Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica CI Analyzer and Atellica CH Analyzer Siemens Material Number (SMN): 11537211

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JIY·March 13, 2024

    Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

    FDA Recall
    Open, Classified ·DePuy Orthopaedics, Inc.·Product code OIY·February 15, 2023

    Iron Deficiency Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code JIY·November 3, 2025

    Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JIY·June 28, 2022

    Alinity c Iron Reagent, Reference Number 08P3920

    FDA Recall
    Open, Classified ·Sentinel CH SpA Via Robert Koch·Product code JIY·September 29, 2023

    IRON assay, Reference Numbers 6K95-41 and 6K95-30

    FDA Recall
    Open, Classified ·Sentinel CH SpA Via Robert Koch·Product code JIY·September 29, 2023

    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

    FDA Recall
    Open, Classified ·Conformis, Inc.·Product code OIY·November 14, 2022

    Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·December 21, 2022

    Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·April 22, 2024

    Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·December 21, 2022

    Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·December 21, 2022

    Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·April 22, 2024

    Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·December 21, 2022

    MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

    FDA Recall
    Open, Classified ·Shimadzu Medical Systems·Product code JAA·January 10, 2022