All About Lawsuits™ » Medical Products

Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall

admin — Fri, 11 Jun 2010 18:02:25 +0000

AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy, when used with an affected battery pack. Related posts:Telebrands Recalls Scarves with Microwaveable Heat Packs Due to Fire and Burn Hazards Mobile Power Packs Recalled By Tumi Due to Fire Hazard Medical Malpractice Lawsuits Accident Lawsuits Infusion Set Needles [Manufactured by [...] Related posts:

Proton Pump Inhibitors (PPI): Class Labeling Change

admin — Wed, 26 May 2010 16:57:35 +0000

Possible increased risk of fractures of the hip, wrist, and spine. Related posts:Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review Zocor (simvastatin): increased risk of muscle injury with high doses Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class [...] Related posts:

Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease

admin — Tue, 25 May 2010 17:00:51 +0000

Study terminated following the identification of an imbalance of thrombosis of the portal venous system in patients treated with eltrombopag versus matching placebo. Related posts:Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment Edwards Lifesciences Aquarius Hemodialysis System: Recall Edwards Lifesciences Aquarius Hemodialysis System: Recall WinRho SDF (Rho(D) Immune [...] Related posts:

Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

admin — Tue, 25 May 2010 16:31:57 +0000

Flex tube may not fit securely within the endotracheal tube (ET) connector. Related posts:Radio Systems Corporation Recalls Power Adapters Sold with PetSafe(r) Heated Wellness Sleepers Due to Fire Hazard KENWORTH ( 10V308000 ) PETERBILT ( 10V308000 ) Comarco Recalls Power Adapters for Laptops Due to Burn Hazard Former Executive Indicted for his Role in Color Display Tube Price-Fixing Conspiracy Related posts:

GE Healthcare Aisys and Avance Anesthesia Systems: Recall

admin — Tue, 25 May 2010 16:30:58 +0000

Defective control board wiring harnesses can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring. Related posts:GE Recalls Front Load Washers Due to Fire and Shock Hazards Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall KIA ( 10V388000 ) KIA MOTOR ( 10V388000 ) Abiomed AB5000 Circulatory Support System: Class [...] Related posts:

Baxter Colleague Infusion Pumps: FDA Ordering Recall

admin — Wed, 05 May 2010 16:50:41 +0000

Action based on failure to correct serious problems with infusion pumps. Related posts:Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall WESTPORT ( 10V165000 ) Promoter of Credit Repair, Debt Relief Services to Settle FTC Charges Amended Class Action filed for Toyota for Accelerator Issue Exjade (deferasirox): Boxed Warning Related posts:

Cardiac Science Automated External Defibrillators – Powerheart, Cardiovive, NK, Responder models: Class I Recall

admin — Thu, 29 Apr 2010 17:09:17 +0000

UPDATED 04/27/2010. FDA’s review of updated software indicates that it detects some but not all electrical component defects. Originally posted 03/08/2010 Related posts:Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Atlas Operations, Inc.: [...] Related posts:

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

admin — Tue, 27 Apr 2010 14:56:20 +0000

Class I Recall issued because of the potential for the device to expectedly power off and/or power on. Related posts:Walmart Gender Bias Class Action Can Proceed Accident Lawsuits Class Action Lawsuits Privacy Immediate Expansion of Toyota Recalls sought by Class Action Lawsuit Related posts:

Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

admin — Tue, 27 Apr 2010 14:55:59 +0000

Recall due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. Related posts:Simplicity Cribs Recalled by Retailers; Mattress-Support Collapse Can Cause Suffocation and Strangulation EPA Takes Action on Underground Petroleum Tanks; Binghamton, N.Y. Gas Stations to Install New Equipment to Ensure Tanks Are Not Leaking (NY) Infusion Set Needles [Manufactured [...] Related posts:

Boston Scientific Implantable Cardioverter Defibrillators: Recall

admin — Wed, 31 Mar 2010 16:46:44 +0000

Practitioners should not use these devices unless and until FDA reviews and approves changes made by the manufacturer. Related posts:Ear Candles: Risk of Serious Injuries Boston and New England Buildings Receive Energy Star Recognition (CT, ME, MA, NH, RI, VT) Accident Lawsuits Privacy Senate Report Questions Avandia Related posts:

Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall

admin — Wed, 31 Mar 2010 16:46:31 +0000

Defective devices may result in air bubbles leaking into the infusion system and into the patient’s bloodstream. Related posts:BD Q-Syte Luer Access Devices: Recall BD Q-Syte Luer Access Devices: Recall GE Healthcare Aisys and Avance Anesthesia Systems: Recall Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes Baxter Colleague Infusion Pumps: FDA Ordering Recall Related posts:

Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall

admin — Wed, 31 Mar 2010 16:45:59 +0000

Device implanted for ventilation or drainage of the middle ear – shipped without being sterilized. Related posts:Ear Candles: Risk of Serious Injuries Abiomed AB5000 Circulatory Support System: Class I Recall Children’s Fork and Spoon Sets Recalled by Peachtree Playthings Due to Choking Hazard; Sold at Dollar Tree and Deals Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Cardiac [...] Related posts:

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall

admin — Wed, 31 Mar 2010 16:45:44 +0000

UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010 Related posts:Cardiac Science Automated External Defibrillators – Powerheart, Cardiovive, NK, Responder models: Class I Recall Atlas Operations, Inc.: Recall of Sexual Enhancement Products Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall McNeil Consumer [...] Related posts:

Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall

admin — Wed, 31 Mar 2010 16:45:31 +0000

Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death. Related posts:Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas [...] Related posts:

Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall

admin — Wed, 31 Mar 2010 16:45:19 +0000

Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. Related posts:Abiomed AB5000 Circulatory Support System: Class I Recall GammaGard Liquid, Immune Globulin Intravenous (Human) Ear Candles: Risk of Serious Injuries Judge Hears Arguments In Challenge To Patents On Genes Tied To Breast, Ovarian [...] Related posts:

StatSpin Express 4 Centrifuges Model 510: Recall

admin — Wed, 31 Mar 2010 16:45:03 +0000

Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms. Related posts:Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall Step2(r) Recalls Basic Rhythms Drum(tm) Toys Due to Choking Hazard Safesheath CSG Coronary Sinus Guide Hemostatic [...] Related posts:

OneTouch SureStep Test Strips (LifeScan): Recall

admin — Wed, 31 Mar 2010 16:44:46 +0000

Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. Related posts:Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall Howard Berger Recalls Extension Cords and Power Strips Due to Fire Hazard Caraco Digoxin Tablets Recalled Outdoor Classrooms to Help Students Test Water Quality [...] Related posts:

Abiomed AB5000 Circulatory Support System: Class I Recall

admin — Wed, 17 Mar 2010 16:16:38 +0000

Device computer may shut down without an alarm, which can lead to serious injuries or death. Related posts:BD Q-Syte Luer Access Devices: Recall BD Q-Syte Luer Access Devices: Recall Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I [...] Related posts:

Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall

admin — Wed, 17 Mar 2010 16:15:51 +0000

Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death. Related posts:Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport [...] Related posts:

Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall

admin — Wed, 17 Mar 2010 16:15:15 +0000

Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell. Related posts:EPA Highlights Recycling Opportunities During National Cell Phone Recycling Week (HQ) Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall Okla. Judge Strikes Down State Law Banning Sex-Selective Abortion, Requiring Reporting Of Personal Information Former [...] Related posts:

Counterfeit Polypropylene Surgical Mesh: Initial Communication

admin — Wed, 17 Mar 2010 16:14:26 +0000

Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name. Related posts:Miami Breaker Recalls Counterfeit Square D Circuit Breakers Due to Fire Hazard Asurion Recalls Counterfeit BlackBerry(r)-branded Batteries Due to Burn and Fire Hazards Commission Approves Carilion Clinic’s Application to Sell Center for [...] Related posts:

Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall

admin — Wed, 17 Mar 2010 16:13:41 +0000

Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged. Related posts:Children’s Deaths Prompt Recall of Toy Dart Gun Sets Sold Exclusively at Family Dollar Stores Violation of Federal Mattress Flammability Standard Prompts Recall of Mattress Sets by Tropical Bedding Hylenex recombinant (hyaluronidase human injection): Recall Accident Lawsuits Privacy Related posts:

Ear Candles: Risk of Serious Injuries

admin — Mon, 22 Feb 2010 17:08:11 +0000

FDA is notifying consumers and healthcare providers of its warning not to use ear candles - a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two - because they can cause serious injuries, even when used according to the manufacturer’s directions. According to advertised claims, a burning ear candle draws ear wax and “impurities” or “toxins” out of the ear canal. Other claims for ear candles include relief from sinus and ear infections, headache and earache, as well as improved hearing, “blood purification,” improvements in brain function, and cure cancer. FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits. FDA has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles.

FDA is especially concerned because some ear candles are being advertised for use in children. Children of any age, including babies, are likely at increased risk for injuries and complications if they are exposed to ear candles. Small children and infants may move during the use of the device, increasing the likelihood of wax burns and ear candle wax plugging up the ear canal. Also, their smaller ear canal size may make children more susceptible than adults to injuries.

Ear candles are sold and promoted in a variety of locations, including health food stores, flea markets, health spas and salons, as well as on commercial web sites.

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical

admin — Mon, 15 Feb 2010 19:50:48 +0000

Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death. Related posts:Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall 32-Inch Sharp LCD-TVs [...] Related posts:

Edwards Lifesciences Aquarius Hemodialysis System: Recall

admin — Mon, 15 Feb 2010 19:50:02 +0000

Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm. Related posts:Edwards Lifesciences Aquarius Hemodialysis System: Recall Abiomed AB5000 Circulatory Support System: Class I Recall Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease SUBARU ( 10V196000 ) Swing Sets Recalled by Kompan Inc. for Repair Due to Fall [...] Related posts:

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall

admin — Mon, 15 Feb 2010 19:49:49 +0000

Plastic centrifuge rotor may crack, break apart and be forcefully ejected. Related posts:Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall StatSpin Express 4 Centrifuges Model 510: Recall Primal Vantage Expands Recall of Plastic Tree Steps Due to Fall Hazard Conair Recalls BabylissPro Compact Hair Dryers Due to Laceration Hazard Kikkerland Design Recalls Foldable Step Stools Sold By QVC Due [...] Related posts:

Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall

admin — Mon, 15 Feb 2010 19:49:37 +0000

Class I recall due to “coring” or dislodging of silicone cores or slivers from the ports into which they are inserted. Related posts:Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall Hylenex recombinant (hyaluronidase human injection): [...] Related posts:

BD Q-Syte Luer Access Devices: Recall

admin — Mon, 15 Feb 2010 19:49:07 +0000

Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. Related posts:BD Q-Syte Luer Access Devices: Recall Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Safesheath [...] Related posts:

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

admin — Mon, 15 Feb 2010 19:48:55 +0000

Device may not be able to deliver therapy during a cardiac resuscitation attempt. Related posts:Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall Cardiac Science Automated External Defibrillators – Powerheart, Cardiovive, NK, Responder models: Class I Recall BD Q-Syte Luer Access Devices: Recall BD Q-Syte [...] Related posts:

Edwards Lifesciences Aquarius Hemodialysis System: Recall

admin — Wed, 10 Feb 2010 19:38:20 +0000