Perinatology & Neonatology Alerts This is an OPML file. It can be used to export all the MedWorm RSS feeds on this topic into your personal RSS reader (usually you have to save this file to your own computer before clicking on an Import OPML command in your own feed reader to upload the file which will then import all the feeds) or it can be used by webmasters to integrate MedWorm feeds with their own website. This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

This page shows you the most recent publications within this specialty of the MedWorm directory.

Embla System Llc - Embletta Gold - Class 2 Recall
embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient. Item Numbers: RMIV003465 RMIV017570 RMRE008075 UI009108 UI010814 UI013848 RMIV019053 RMIV019328 RMIV019340 ...
Source: Medical Device Recalls - June 11, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, CARESCAPE Monitor B650 - Class 2 Recall
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcarr Dash Port 2 Docking Station - Class 2 Recall
GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. - Class 2 Recall
Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. The intended use of the system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2013 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - Mindray DS USA Inc. - Class 2 Recall
DPM5 Monitor Product Usage: A vital signs monitor used on human patients. The target populations are adult, pediatric, and neonatal patients. The DPM5 Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and intuitive menu system. The patient parameters that can be monitored by DPM5 monitors are ECG (3- lead or 5-lead selectable), Heart Rate (HR), Pulse Rate(PR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP) , Saturation of Pulse Oxygen (SpO2), Temperature (TEMP), Invasive Blood Pressure (IBP), Carbon Dioxide (CO), Anesthetic Gases (AG) . Its design allows the oper...
Source: Medical Device Recalls - January 27, 2013 Category: Medical Equipment Source Type: alerts

Perkinelmer - Perkin Elmer NEONATAL TOTAL GALACTOSE KIT - Class 2 Recall
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 16, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Giraffe and Panda Warmer TPiece Resuscitation System - Class 1 Recall
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 26, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, Dash 3000/4000/5000. - Class 2 Recall
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medi...
Source: Medical Device Recalls - December 16, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Carescape Patient Data Module v2.0 - Class 2 Recall
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 14, 2012 Category: Medical Equipment Source Type: alerts

Metrex Research, LLC. - CaviCide - Class 2 Recall
CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bott...
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Natus Medical Incorporated - Olympic CoolCap System - Class 2 Recall
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Ca...
Source: Medical Device Recalls - June 20, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial - Class 2 Recall
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10440017 - ACUSON S2000 Refurb. Mainframe; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in ...
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - Siemens brand ACUSON S2000 Ultrasound Systemsand the Advanced SieClearTM spatial, - Class 2 Recall
Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 - ACUSON S2000 Mainframe; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA The ACUSON S2000 Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, ...
Source: Medical Device Recalls - May 30, 2012 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - ACCUCHEK Aviva Nano Blood Glucose Meter - Class 2 Recall
ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached. The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The system is intended to be used by a single person and should not be shared. The system is intended for...
Source: Medical Device Recalls - April 9, 2012 Category: Medical Equipment Source Type: alerts

Oridion Medical 1987 Ltd. - Class 2 Recall
Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579; FilterLine H Set Adult/Pediatric -Part No. XS04624 ; FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580; FilterLine H Set Infant/Neonatal-Part No. 006324; FilterLine Set Adult/Pediatric Long Part No. 007768; FilterLine H Set Adult/Pediatric Long Part No. 007737; FilterLine H Set Infant/Neonatal Long Part No. 007738 Smart CapnoLine Plus (O2 connector) Part No. 009818 Smart CapnoLine Plus (O2 ...
Source: Medical Device Recalls - March 29, 2012 Category: Medical Equipment Source Type: alerts

Hamilton Medical Inc - HamiltonG5 Ventilator - Class 2 Recall
HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2012 Category: Medical Equipment Source Type: alerts

Nemschoff Chairs, Inc. - Bassinet - Class 1 Recall
Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 1, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE LOGIQ P6 Ultrasound System - Class 2 Recall
GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and intraoperative (abdominal, thoracic, vascular and neurological). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2012 Category: Medical Equipment Source Type: alerts

Hemo Cue, Inc. - HemoCue Glucose 201 Microcuvettes, - Class 3 Recall
HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**, 110719** " No affected lots of this article have been delivered to customers. Still in stock at distributor HemoCue Inc. "" Article not available in US Quantitative determination of glucose in whole blood, using a specially designed analyzer, the HemoCue Glucose 201 Analyzer. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose le...
Source: Medical Device Recalls - January 20, 2012 Category: Medical Equipment Source Type: alerts

Smiths Medical ASD, Inc. - Bivona TTS Cuffed Neonatal Tracheostomy Tube - Class 1 Recall
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2012 Category: Medical Equipment Source Type: alerts

Smiths Medical ASD, Inc. - Bivona Uncuffed Neonatal Tracheostomy Tube - Class 1 Recall
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2012 Category: Medical Equipment Source Type: alerts

Smiths Medical ASD, Inc. - Bivona TTS Cuffed Neonatal Tracheostomy Tube - Class 1 Recall
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2012 Category: Medical Equipment Source Type: alerts

Smiths Medical ASD, Inc. - Bivona Uncuffed Neonatal Tracheostomy Tube - Class 1 Recall
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2012 Category: Medical Equipment Source Type: alerts

Smiths Medical ASD, Inc. - Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube - Class 1 Recall
"Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2012 Category: Medical Equipment Source Type: alerts

Smiths Medical ASD, Inc. - Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube - Class 1 Recall
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2012 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - Colleague 3 Volumetric Infusion Pump - Class 2 Recall
Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8153. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - Colleague CX Volumetric Infusion Pump - Class 2 Recall
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Carefusion 211 Inc - AVEA Ventilator - Class 1 Recall
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. - Class 2 Recall
GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - TERUMO 3T L. V. Control Valve - Class 2 Recall
Cardiovascular Custom Procedure Kits, REV.4, REV. 5 X-COATED NEONATAL PACK 3/16" Item Number: 72651-02 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 16, 2011 Category: Medical Equipment Source Type: alerts

Cincinnati Sub-Zero Products Inc - WarmAir Model 135 Hyperthermia System and Blankets - Class 2 Recall
Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facili...
Source: Medical Device Recalls - September 1, 2011 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors - Class 2 Recall
GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, c...
Source: Medical Device Recalls - August 25, 2011 Category: Medical Equipment Source Type: alerts

Draeger Medical Systems, Inc. - Gamma X XL Portable Patient Monitor - Class 2 Recall
Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2011 Category: Medical Equipment Source Type: alerts

Draeger Medical Systems, Inc. - Infinity Delta Portable Patient Monitor - Class 2 Recall
Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2011 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - Colleague CX Infusion Pump - Class 2 Recall
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 11, 2011 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - Colleague CX Infusion Pump - Class 2 Recall
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 8, 2011 Category: Medical Equipment Source Type: alerts

Welch Allyn Protocol, Inc - Aruba Wireless Access Points, Model 65 - Class 2 Recall
Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Welch Allyn Protocol, Inc. Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 2011 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - Colleague CX Infusion Pump - Class 2 Recall
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 19, 2011 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - Colleague 3 and 3 CX Infusion Pumps - Class 2 Recall
Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 13, 2011 Category: Medical Equipment Source Type: alerts

Spacelabs Healthcare, Llc - Ultraview SL Capnography Module - Class 2 Recall
The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 grams), or single-use airway adapters are available for both adult and neonatal (low dead space) patients. Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tubes using the mainstream funct...
Source: Medical Device Recalls - June 20, 2011 Category: Medical Equipment Source Type: alerts

Hitachi Medical Systems America Inc - HIVISION Preirus, Avius ultrasound systems - Class 2 Recall
Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are ...
Source: Medical Device Recalls - June 8, 2011 Category: Medical Equipment Source Type: alerts

Abbott Laboratories - ARCHITECT HAVABM Assay Reagent - Class 2 Recall
ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum; Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA, List 6L21-25 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2011 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - MICROSTREAM FILTERLINE ICU - Class 1 Recall
Philips Microstream¿ Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2011 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - MICROSTREAM FILTERLINE ICU - Class 1 Recall
Philips Microstream¿ Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2011 Category: Medical Equipment Source Type: alerts

Oridion Medical 1987 Ltd. - MicroStream Filterline ICU - Class 1 Recall
MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 25, 2011 Category: Medical Equipment Source Type: alerts

Oridion Medical 1987 Ltd. - MicroStream Filterline ICU - Class 1 Recall
MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 25, 2011 Category: Medical Equipment Source Type: alerts

Oridion Medical 1987 Ltd. - MicroStream Filterline ICU - Class 1 Recall
Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 25, 2011 Category: Medical Equipment Source Type: alerts

Oridion Medical 1987 Ltd. - MicroStream Filterline ICU - Class 1 Recall
MicroStream Filterline Infant/Neonatal products: Part # 008598 - FILTERLINE H SET INF/NEO 25UN DRAEGER(Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 25, 2011 Category: Medical Equipment Source Type: alerts

Maker Pulls Neonate CO2 Sampling Line
(MedPage Today) -- The distributor of a line of neonatal carbon dioxide sampling lines has recalled the product because of the presence of dislodged plastic strands, which may cause serious injury or death if inhaled. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - May 24, 2011 Category: Drugs & Pharmacology Source Type: alerts

Deroyal Industries, Inc. Lafollette - GEOMED BIOPSY TRAY - Class 2 Recall
Kits and Trays containing alcohol swabstick/prep pad: GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01 Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) ST TPN/CVC DRG KIT W/VAD, REF 47-003, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TPN/CVC Dressing Change Kit, REF 47-094.019, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TPN/CVC DRG CHG KIT, REF 47-276.13, Rx Only, STERILE EO, Manufacturer: DeR...
Source: Medical Device Recalls - May 20, 2011 Category: Medical Equipment Source Type: alerts