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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

    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

    FDA Recall
    Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

    FDA Recall
    Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code JET·July 2, 2018

    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code KMA·April 3, 2012

    Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014

    FDA Recall
    Terminated ·Dokitz NovoSci·Product code DTL·September 18, 2014

    Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683 Item # FIY-2210 Intended use: Intravascular Administration Set

    FDA Recall
    Terminated ·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010

    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

    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

    FDA Recall
    Terminated ·Hitachi America, Ltd., Power Systems Division·Product code LHN·April 15, 2019

    Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.

    FDA Recall
    Terminated ·Vistakon·Product code LPM·July 16, 2010

    BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code PIC·January 14, 2019

    Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and 3-I7504-BUF. Clinical chemistry reagent for the quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JIY·November 16, 2009

    3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

    FDA Recall
    Terminated ·Product code OIY·April 1, 2013

    Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JIY·November 16, 2009

    Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: HI704-300, HI904-1200, HI904-498, HI904-600, HI904-SAM-911, HI904-SAM-917 and 12-HI904-144. Clinical chemistry reagent for the quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JIY·November 16, 2009

    Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7505-120, I7505-500. Clinical chemistry reagent for the quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code JIY·November 16, 2009