All About Lawsuits™ » Medical Products

Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall – Risk of Injury to Patients

admin — Sat, 25 Feb 2012 14:54:24 +0000

Doors and drawers may inadvertently open while bassinet is in motion; product may be difficult to maneuver due to it swivel caster configuration. Related posts: CAN-AM ( 11V081000 ) Violation of Federal Mattress Flammability Standard Prompts Recall of Ottoman Bed Mattresses by PBteen Photon Climbing Carabiners and Quickdraws Recalled Due to Risk of Injury Petzl [...] Related posts:

Xigris [drotrecogin alfa (activated)]: Market Withdrawal – Failure to Show Survival Benefit

admin — Tue, 06 Dec 2011 01:23:05 +0000

In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock. Related posts: Mylotarg (gemtuzumab ozogamicin): Market Withdrawal Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment Velcade (bortezomib): Starting Dose Adjustments for Patients with [...] Related posts:

Virility Max: Recall – Undeclared Drug Ingredient

admin — Mon, 05 Dec 2011 16:08:16 +0000

Product marketed as dietary supplement contains sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Related posts: Magic Power Coffee: Undeclared Drug Ingredient Atlas Operations, Inc.: Recall of Sexual Enhancement Products MasXtreme Capsules (Natural Wellness) – product contains undeclared drug ingredient Birth Defects Caused by Dangerous [...] Related posts:

CooperVision Avaira Toric Soft Contact Lenses: Class 1 Recall- Unintended Residue on Lenses

admin — Mon, 05 Dec 2011 09:33:24 +0000

Presence of a silicone oil residue on lenses from certain lots of my cause range of symptoms such as hazy, blurry vision, discomfort to eye injuries requiring medical treatment. Related posts: CooperVision "Avaira" Contact Lens Recall Problems Continue FTC Requires Three Internet Marketers to Stop Selling "Circle" Cosmetic Contact Lenses without Prescriptions as Part of [...] Related posts:

Chantix (varenicline)

admin — Mon, 05 Dec 2011 08:21:36 +0000

UPDATED 10/24/2011. Updated study data. Healthcare professionals should continue to monitor patients for neuropsychiatric symptoms. Related posts: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication Sprycel (dasatinib): Drug Safety Communication – Risk of Pulmonary Arterial Hypertension Mesothelioma Patients’ Lives Extended Years In Study Cardiac Science Automated External Defibrillators – Powerheart, Cardiovive, NK, Responder [...] Related posts:

Mizuho OSI Modular Table Systems: Class I Recall – Reports of Patient Injury

admin — Thu, 10 Nov 2011 17:44:45 +0000

Potential for patient falls or unanticipated patient movement, which may result in serious injury or death. Related posts: Recall to Repair: Whitco Company LP Stadium Light Poles Can Fall Over, Posing Risk of Serious Injury and Death Photon Climbing Carabiners and Quickdraws Recalled Due to Risk of Injury Medical Malpractice Lawsuits BD Q-Syte Luer Access [...] Related posts:

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: OneTouch SureStep Test Strips (LifeScan): Recall Extech Instruments Recalls Digital Clamp and Multimeters due to Electrocution Hazard American Suzuki Motor Corp. Recalls QuadSport ATVs Due to Crash [...] 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 Serious Head Injuries to Infants Continue Due to Falls from Bumbo Baby Seats Used on Elevated Surfaces; Injuries occurring despite [...] 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: Mesothelioma Patients’ Lives Extended Years In Study Edwards Lifesciences Aquarius Hemodialysis System: Recall Edwards Lifesciences Aquarius Hemodialysis System: Recall Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment Velcade [...] 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 PETERBILT ( 10V308000 ) KENWORTH ( 10V308000 ) Comarco Recalls Power Adapters for Laptops Due to Burn Hazard Stained Glass Soldering Irons Recalled By Cooper [...] 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: Exmark Recalls Pioneer S-Series Mowers Due to Crash Hazard Mizuho OSI Modular Table Systems: Class I Recall – Reports of Patient Injury GE Recalls Front Load Washers Due to Fire and Shock [...] 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: ITT Water Technology Recalls Pumps Due to Electric Shock/Electrocution Hazard Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall FTC Seeks Public Comment on Cardinal Health, Inc.’s Application to Sell Nuclear Pharmacy Assets to Patient Care Infusion, LLC Promoter [...] 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 [...] 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: MERCEDES BENZ ( 10V459000 ) Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall FLEETWOOD ( 10V539000 ) Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, [...] 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 [...] 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 Nursing Workforce Issues: An Expanded Role For Nurse Practitioners, Calif. Doctors Sue For Supervision Of Nurse Anesthetists FDA Takes Legal Action Against Dietary Supplement Maker In Pennsylvania Senate Report [...] 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 Mizuho OSI Modular Table Systems: Class I Recall – Reports of Patient Injury GE Healthcare Aisys and Avance Anesthesia Systems: Recall GREAT DANE ( [...] 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 Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall – Possibility of Inexact Tablet Counts or Out of Sequence Tablets Abiomed AB5000 Circulatory Support System: Class I Recall Children’s Fork and Spoon Sets Recalled by Peachtree Playthings [...] 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, [...] 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 [...] 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: 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 Cancer Proton Pump [...] 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 Chuck E. Cheese’s Recalls Light-up Rings and Star Glasses Due to [...] 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: Extech Instruments Recalls Digital Clamp and Multimeters due to Electrocution Hazard Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall Howard Berger Recalls Extension Cords and Power Strips [...] 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 Briggs & Stratton Recalls Model 40 V-Twin Engine Due to Injury Hazard; Used on Sears, Husqvarna, Bad Boy Riding Mowers Baxter HomeChoice and HomeChoice PRO [...] 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 [...] 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) Lithium-Ion Batteries Used with Bicycle Lights Recalled by GeoManGear Due to Fire Hazard Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog [...] 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 CPSC Alert: Counterfeit Smoke Alarms Distributed in Atlanta Winter Weather Warning: CPSC and USFA Issue Home [...] 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: CPSC Adopts Independent Third Party Testing and Certification Rules for Children’s Products Government Investigation Raises Concerns About Pool and Spa Drain Cover Testing and Entrapment Risks Cincinnati Packaged-Ice Manufacturer Sentenced to Pay $9 [...] 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 [...] Related posts: