Welch Allyn Protocol, Inc - Propaq LT 802LT series Vital Signs Monitor - Class 2 Recall
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and a...
Source: Medical Device Recalls - January 8, 2014 Category: Medical Equipment Source Type: alerts
Wexford Labs Inc - Ready To Use ThymoCide - Class 2 Recall
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 20, 2013 Category: Medical Equipment Source Type: alerts
Cordis Corporation - Cordis OPTEASE Vena Cava Filter - Class 2 Recall
Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 26, 2013 Category: Medical Equipment Source Type: alerts
H & H Associates - H&H Emergency Cricothyrotomy Kit - Class 1 Recall
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2013 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch Systems Made in China Tegris system (1703.01) MAQUET GmbH & Co. KG Kehler Strabe 31 76437 Rastatt, Germany OR Table Module (1703.71) MAQUET GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Designed to be used as the central operating s...
Source: Medical Device Recalls - September 26, 2013 Category: Medical Equipment Source Type: alerts
Cordis Corporation - OptEase Vena Cava Filter - Class 1 Recall
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of an...
Source: Medical Device Recalls - August 8, 2013 Category: Medical Equipment Source Type: alerts
Hill-Rom, Inc. - TotalCare Bed (1900) - Class 2 Recall
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determ...
Source: Medical Device Recalls - July 24, 2013 Category: Medical Equipment Source Type: alerts
Linde Gas North America Llc - MEDICYCLE Lite Portable Oxygen System - Class 2 Recall
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2013 Category: Medical Equipment Source Type: alerts
Shimadzu Medical Systems - Mobile DaRt Evolution - Class 2 Recall
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency . (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 4, 2013 Category: Medical Equipment Source Type: alerts
Heart Sync, Inc - Heart Sync C100Physio Radiotransparent Defibrillation Electrodes - Class 2 Recall
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 31, 2013 Category: Medical Equipment Source Type: alerts
Heart Sync, Inc - Vermed, Inc Radiotransparent Defibrillation Electrodes - Class 2 Recall
Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 31, 2013 Category: Medical Equipment Source Type: alerts
TZ Medical Inc. - Medtronic/Physio Control Transparent Defibrillation Electrodes - Class 2 Recall
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 31, 2013 Category: Medical Equipment Source Type: alerts
Hologic, Inc. - Fluoroscan Mini Carm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 - Class 2 Recall
Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2013 Category: Medical Equipment Source Type: alerts
Hologic, Inc. - Fluoroscan Mini Carm InSight, software versions 1.x, 2.x, 3.x - Class 2 Recall
Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 18, 2013 Category: Medical Equipment Source Type: alerts
Instrumentation Industries Inc - Manual Jet Ventilators, Manual Jet Ventilators w/Regulator and Guage, Small Bore Tubing Assembly - Class 2 Recall
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2013 Category: Medical Equipment Source Type: alerts
