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    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code CBK·May 10, 2021

    VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code CBK·February 3, 2025

    VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code CBK·May 8, 2026

    VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code NOU·March 25, 2026

    LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT (0-14CC) US), B-2210 (LP-BND SYS, 9.75, STER, US), B-2215 (LAP-BAND 9.75 W/ACC PRT II US), B-2220 (LP-BND SYS, 10.0, STER, US), B-2225 (LAP-BND 10.0,ACCESS PORT II,US), B-2255 (LAP-BAND VG W/ACS PORT II (US), B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II), B-2265 (LP-BND AP LG SYS, W/ACC PRT II); The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline.

    FDA Recall
    Terminated ·Allergan·Product code LTI·September 16, 2010

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PEN·October 17, 2023

    Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.

    FDA Recall
    Terminated ·Restoration Robotics·Product code ONA·October 13, 2013

    VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients

    FDA Recall
    Open, Classified ·Percussionaire Corporation·Product code CBK·December 23, 2024

    VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code CBK·January 9, 2024

    Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott Item Number: PRT 03831-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number: PRT 03415-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-091, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbott Item Number: PRT 03831-002, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code KCY·March 1, 2023

    Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code KCY·July 2, 2025

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code KCY·March 1, 2023

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code KCY·March 1, 2023

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007