Anesthesiology 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.

Symbios Medical Products, LLC - GOPump - Class 1 Recall
Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH GoPump Kit 510110, w/2.5" Fenestrated Catheter GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH Symbios GOPump Rapid Recovery System is a local pain mangagement sys...
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

Symbios Medical Products, LLC - GOPump - Class 1 Recall
Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

Symbios Medical Products, LLC - GOPump - Class 1 Recall
Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

Symbios Medical Products, LLC - GOPump - Class 1 Recall
Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

Symbios Medical Products, LLC - GOPump - Class 1 Recall
Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5" Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch GoPump Kit 510205BP, 5" Fenestrated catheter & Biopatch GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch GoBlock kit 510608 Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

Symbios Medical Products, LLC - GOPump - Class 1 Recall
Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit 510141-BP,10" fenestrated catheter& BIOPATCH Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems - Class 2 Recall
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2013 Category: Medical Equipment Source Type: alerts

Cardinal Health, Medical Products & Services - Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit - Class 1 Recall
Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2013 Category: Medical Equipment Source Type: alerts

Engineered Medical Systems,Inc - SealFlex - Class 1 Recall
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. . (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 10, 2013 Category: Medical Equipment Source Type: alerts

Cooper Surgical, Inc. - LEEP - Class 2 Recall
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 3, 2013 Category: Medical Equipment Source Type: alerts

Smiths Medical ASD, Inc. - BCI Remote Alarm Cable Normally Open /Normally Closed - Class 1 Recall
Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI¿ Remote Alarm Cable is designed for use with the 9004 Capnocheck¿ Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck¿ Capnography system to a remote alarm system. The BCI¿ Remote Alarm Cable and the 9004 Capnocheck¿ Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia. (Sou...
Source: Medical Device Recalls - March 29, 2013 Category: Medical Equipment Source Type: alerts

CareFusion Corporation - Pyxis - Class 2 Recall
Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2013 Category: Medical Equipment Source Type: alerts

Del Mar Reynolds Medical, Ltd. - BleaseFocus Anesthesia Workstations - Class 1 Recall
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2013 Category: Medical Equipment Source Type: alerts

Hill-Rom, Inc. - TotalCare SpO2RT 2 bed - Class 2 Recall
TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed 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 SpO2RT¿ 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 14, 2013 Category: Medical Equipment Source Type: alerts

Breg Inc, An Orthofix Company - BREG Cold Therapy Combination Units - Class 2 Recall
BREG Cold Therapy Combination Units containing Sterile Polar Pads. Breg, Inc., 2885 Loker Ave, E., Carlsbad, CA 92010; 02356 Rev M, PAD M/U XL STER, Assembled in Mexico, Box 24, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Breg Inc, An Orthofix Company - BREG Sterile Polar Pads - Class 2 Recall
BREG Sterile Polar Pads, Breg, Inc., 2885 Loker Ave, E., Carlsbad, CA 92010; 02356 Rev M, PAD M/U XL STER, Assembled in Mexico, QTY 1, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410. Local anesthetic effect. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 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

Del Mar Reynolds Medical, Ltd. - BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators - Class 2 Recall
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 19, 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

Mindray DS USA, Inc. d.b.a. Mindray North America - Mindray DS USA Inc. - Class 2 Recall
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) a...
Source: Medical Device Recalls - December 11, 2012 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - A3/A5 Anesthesia Delivery System - Class 1 Recall
Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2012 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - A3/A5 Anesthesia Delivery System - Class 1 Recall
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2012 Category: Medical Equipment Source Type: alerts

First Medical Source LLC - WOLFPAK, Medpro, Vipat - Class 1 Recall
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer s package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperative...
Source: Medical Device Recalls - October 30, 2012 Category: Medical Equipment Source Type: alerts

First Medical Source LLC - WOLFPAK, Medpro, Vipat - Class 2 Recall
Medpro Eslatomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer s package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperative...
Source: Medical Device Recalls - October 30, 2012 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - FLOWI Anesthesia System - Class 1 Recall
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 6, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Single Shot Epidural Tray - Class 3 Recall
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 5, 2012 Category: Medical Equipment Source Type: alerts

SALTER LABS - Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector - Class 2 Recall
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Aestiva/5 7900 SmartVent - Class 1 Recall
GE Healthcare, Aestiva/5 7900 SmartVent", anesthesia machine, GE Healthcare P.O. Box 7550 Madison, WI 53707-7550. This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration...
Source: Medical Device Recalls - June 17, 2012 Category: Medical Equipment Source Type: alerts

Penlon, Ltd. - Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display - Class 2 Recall
Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2012 Category: Medical Equipment Source Type: alerts

Nellcor Puritan Bennett Inc. (dba Covidien LP) - BIS BILATERAL SENSOR - Class 1 Recall
BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patient s forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 26, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain including (1) Cranial Kit W/Cam. Chuck, (1) Ventricular Bolt ICP Monitoring Kit, (1) CSF Drainage System. Contains Sterile and Non-Sterile Product. Integra Life Sciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial pressure & temperature monitoring kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP Monitoring Kit, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitoring Kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. d.b.a. Integra Pain Management - Class 2 Recall
Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro, NJ 08536 Contents Sterile and non-sterile, Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2012 Category: Medical Equipment Source Type: alerts

Intersurgical Inc - IS Can Disposable CO2 absorber - Class 2 Recall
The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts

Arrow International Inc - Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH - Class 2 Recall
Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039 Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 30, 2011 Category: Medical Equipment Source Type: alerts

Picis Inc. - Picis Anesthesia Manager - Class 2 Recall
Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for i...
Source: Medical Device Recalls - October 31, 2011 Category: Medical Equipment Source Type: alerts

Deroyal Industries, Inc. Lafollette - DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits - Class 2 Recall
Custom anesthesia kits labeled as follows: (1) DeRoyal (R) Adult Exp Anesthesia Circuit, REF 86-001737, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Number 25660996 (2) DeRoyal (R) Adult Anesthesia Circuit, REF 86-001781, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Numbers: 25574115, 25624514, 25661260, 25702578, 25766272, 25835901, 25835910, 25873406, 25906061, 25960681 (3) DeRoyal (R) Latex Safe Anesthesia Kit, REF 86-001641, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBus...
Source: Medical Device Recalls - October 6, 2011 Category: Medical Equipment Source Type: alerts

Deroyal Industries, Inc. Lafollette - DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits - Class 2 Recall
DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 6, 2011 Category: Medical Equipment Source Type: alerts

Picis Inc. - CareSuite Critical Care Manager, PACU Manager and Anesthesia Manager - Class 2 Recall
CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data. This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational pu...
Source: Medical Device Recalls - September 23, 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