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FDA Drug & Medical Device Recall News & Comments 
Wednesday, September 30 2009

Penumbra Announces Worldwide Voluntary Field Removal of the Original Version of 6F Neuron 070 Delivery Catheter

FOR IMMEDIATE RELEASE - September 29, 2009 - ALAMEDA, CA - (BUSINESS WIRE)-

Penumbra is initiating a voluntary Field Removal of the original version of Neuron 6F 070 Delivery Catheter. For these catheters, Penumbra has received feedback from some users that the catheter could kink or ovalize in certain anatomical situations. This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death.

Consumers who have the older version of 6F Neuron 070 Delivery Catheter which is being recalled should stop using and return the device. If your facility is in possession of units with Lot numbers F14630 or higher, you may continue to use these units. Units with Lot numbers F14630 or higher are not affected by this Field Removal Action.

The following product catalog numbers and Lot numbers are affected by this Field Removal. Neuron Delivery Catheter 070 catalog number: PND6F0701058, PND6F0701058M, PND6F070956 and PND6F070956M. Affected Lot numbers include: F13733, F13751, F13773, F13799, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F14103, F14150, F14182, F14183, F14427, F14482, F14560 and F14629.

Penumbra voluntarily conducted a field removal of the devices after learning about the devices potential to kink or ovalize. FDA has been apprised of this action.

There are four injury reports to date, which may be potentially associated with this defect.

Penumbra is notifying affected hospitals through detailed Field Removal notification letters requesting that affected product be returned to Penumbra. Replacement product will be available for all affected customers. Consumers with questions may contact Penumbra directly at 1-888-272-4606 or 510-748-3200.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax

Penumbra Catheter Injury Lawsuit

If you or a loved one have have been injured, had a stoke, heart attack or any of serious injury as a result of a recalled or defective Penumbra Catheter, then call us to discuss your legal rights to monetary compensation for your injuries, stroke, heart attack or the death of a loved one due to a Penumbra catheter. The Willis Law Firm has represented thousands of clients across the United States in defective and recalled medical devices, recalled drugs and other product liability claims. Mr. Willis is a Board Certified Trial Lawyer with 25+ years of legal experience. Call us at 1-800-883-9858 or fill out our online case form.

Posted by: AT 07:11 pm   |  Permalink   |  Email
Monday, September 28 2009

Nutricia North America, Inc. ("Nutricia") has contacted customers to undertake the voluntary recall and replacement of one (1) lot of the specialized infant formula product, NeocateŽ. This recall involves a limited quantity of individual cans (approximately 3700) from Lot # P91877, and does not affect any other NeocateŽ products or lot numbers. September 28, 2009

Read More: Infant Formula Recall

Posted by: dw AT 05:44 pm   |  Permalink   |  Email
Friday, September 25 2009

Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis

FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.

Read the complete MedWatch 2009 Safety summary including a link to the Information for Healthcare Professionals sheet, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183800.htm
Posted by: dw AT 11:18 am   |  Permalink   |  Email
Thursday, September 24 2009

Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit

Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers

FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in a physical interference between the SC catheter connector and the IsoMed pump. This may prevent the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure and may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.

SC catheters are not compatible with IsoMed pumps but are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. To date, Medtronic has received ten reports worldwide related to improper connection of an SC catheter to an IsoMed pump.  In all ten reports, medical intervention was required to correct the condition. Medtronic has provided recommendations in their Medical Device Correction Letter (see link in FDA Recall Notice). 

Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183753.htm
Posted by: DW AT 11:21 am   |  Permalink   |  Email
Tuesday, September 22 2009

FDA reports that Tysabri (Natalizumab) may cause PML

The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.  Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn's disease in January 2008.  From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy.  Of these, four cases were patients in the United States (U.S.).  There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn's disease.  Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. 

For more information see: Tysabri (Natalizumab) PML Lawsuit

The risk for developing PML appears to increase with the number of Tysabri infusions received.  The number of monthly infusions of Tysabri in the 13 patients who developed PML ranged from 12 to 35 infusions.  The average number of infusions received before the diagnosis of PML was 25. There is minimal experience in patients who have received more than 35 infusions of Tysabri.

The overall rate of developing PML with Tysabri therapy in patients who have received at least one infusion remains below one per 1,000 patients.  Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.

At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program.  All patients receiving Tysabri therapy in the U.S. must be enrolled in the TOUCH Prescribing Program.  Under this program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections

Tysabri PML Lawsuit

If you or a loved one have taken Tysabri (Natalizumab) and have been diagnosed with progressive multifocal leukoencephalopathy (PML), then call for a free case consultation. Talk to a Board Certified Personal Injury Trial Lawyer with over 25+ years experience Call 1-800-883-9858 or Click Here for a Online Form

Posted by: DW AT 08:52 am   |  Permalink   |  Email
Tuesday, September 22 2009

Natalizumab (marketed as Tysabri)

[Posted 09/17/2009] FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.  Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn's disease in January 2008.  From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn's disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.

SEE: Tysabri Progressive Multifocal Leukoencephalopathy (PML) Lawsuit - Talk to a Lawyer

The risk for developing PML appears to increase with the number of Tysabri infusions received. At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program. 

Progressive multifocal leukoencephalopathy (PML) is caused by the reactivation of a common virus in the central nervous system of immune-compromised individuals.  Polyomavirus JC (often called JC virus) is carried by a majority of people and is harmless except among those with lowered immune defenses.  The disease occurs, rarely, in organ transplant patients; people undergoing chronic corticosteroid or immunosuppressive therapy; and individuals with cancer, such as Hodgkin's disease, lymphoma, and sarcoidosis.  PML is most common among individuals with acquired immune deficiency syndrome (AIDS).

[09/16/2009 -FDA Tysabri Information For Healthcare Professionals - FDA

Tysabri PML Lawsuit

If you or a loved one have taken Tysabri (Natalizumab) and have been diagnosed with progressive multifocal leukoencephalopathy (PML), then call for a free case consultation. Talk to a Board Certified Personal Injury Trial Lawyer with over 25+ years experience Call 1-800-883-9858 or Click Here for a Online Form

 

Posted by: DW AT 08:46 am   |  Permalink   |  Email
Monday, September 21 2009

Dilantin Can Cause Stevens Johnson Syndrome (SJS)

New studies indicate that Dilantin an antiepileptic drug is known to cause a rare and serious skin and mucous membrane disorder can cause Dilantin Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). SJS can result in the epidermis (the outer layers of skin) separating from the dermis (inner layers of skin). Dilantin side effects can be serious !  Dilantin products under consideration for a Dilantin Lawsuit include Dilantin, Dilantin Generic Name: phenytoin (oral) and other Dilantin generic & Dilantin brand names include Dilantin Infatabs, Dilantin Kapseals, Dilantin-125, Phenytek, Phenytoin Sodium and Prompt. 

Dilantin Side Effects Update

Click Here: Dilantin Stevens Johnson Syndrome information

Posted by: DW AT 11:10 am   |  Permalink   |  Email
Wednesday, September 16 2009

FDA WARNING: Promethazine Hydrochloride Injection

For Immediate Release: Sept. 16, 2009

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA's authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.

Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, the boxed warning says. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.

A requested revision in the Dosage and Administration section of the label states that if health care professionals choose to administer promethazine intravenously, they should limit the drug's concentration and rate of administration and ensure a properly functioning intravenous line.

The companies that make promethazine are required to submit the requested safety label changes to the FDA within 30 days or provide a reason why they do not believe such changes are necessary. If they do not submit new language, or the FDA disagrees with the language proposed by the companies, the agency can order the label change as deemed appropriate to address the new safety information.

Promethazine was previously sold under the brand name Phenergan, but that formulation was discontinued by Wyeth Pharmaceuticals Inc.  A number of companies currently market generic formulations of promethazine hydrochloride injection.

The FDA previously informed consumers and health care professionals about the risks of incorrect administration of promethazine in the December 2006 and February 2008 editions of FDA Patient Safety News. Current prescribing information for the drug contains information about the risk of tissue injury, possibly including gangrene, if the drug is inadvertently administered in the artery, but that information was not highlighted in a boxed warning. 

Promethazine first went on the market in 1956. FDA has reviewed the published literature and post-marketing adverse event reports submitted to the agency's Adverse Event Reporting System from 1969 to 2009 and identified cases of gangrene requiring amputation associated with administration of the drug.

More information is available in this Information for Healthcare Professionals

 

Promethazine Hydrochloride Injection Lawsuit - Talk to a Lawyer

If you or a loved one have suffered a serious injury or death as a result of the use or misuse of the above product, then please call us for a Free Confidential Case Consultation. Talk to a Board Certified Personal Injury Trial Lawyer with more than 25+ years of experience call 1-800-883-9858

Posted by: dw AT 11:56 am   |  Permalink   |  Email
Monday, September 14 2009
Dilantin Stevens-Johnson Syndrome (SJS)

Dilantin is an antiepileptic drug, prescribed to control grand mal seizures (a type of seizure in which the individual experiences a sudden loss of consciousness immediately followed by generalized convulsions) and temporal lobe seizures (a type of seizure caused by disease in the cortex of the temporal [side] lobe of the brain affecting smell, taste, sight, hearing, memory, and movement).

Dilantin is prescribed to help prevent and treat seizures occurring during and after neurosurgery (surgery of the brain and spinal cord). Dilantin Generic Name: phenytoin (oral) and other Dilantin generic & Dilantin brand names include Dilantin Infatabs, Dilantin Kapseals, Dilantin-125, Phenytek, Phenytoin Sodium, Prompt.

Dilantin and SJS

Stevens Johnson Syndrome is a rare and serious disease that affects the mucous membranes and the skin, eventually resulting in the epidermis (the outer layers of skin) separating from the dermis (inner layers of skin). SJS is closely related to TENS (Toxic Epidermal Necrolysis), which affects the skin in the same way but can lead to the separation of one hundred percent of the epidermis. SJS is said to be a milder form of TENS, affecting up to thirty percent or more of the epidermis. SJS has been linked to many prescription medications and a multitude of common over-the-counter treatments as well. Stevens Johnson Syndrome is similar to Lyell's Syndrome

Dilantin SJS Lawsuit

If you or a loved one have used Dilantin and developed Stevens-Johnson Syndrome (SJS) or TENS, then call our law firm and discuss what legal options may be available for you in a product liability lawsuit against the makers of Dilantin. Talk to a Board Certified Personal Injury Trial Lawyer about your case.

Click Here for a Free Dilantin SJS Lawsuit Review

Posted by: DW AT 04:41 pm   |  Permalink   |  Email
Monday, September 14 2009

Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors

FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.

Read the complete MedWatch 2009 Safety summary, including links to the FDA Public Health alert, Dear Healthcare Professional letter [Roche] and Information for Pharmacists [CDC], at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183714.htm
Posted by: dw AT 02:38 am   |  Permalink   |  Email
Friday, September 11 2009

Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm)

Audience: Anesthesiology healthcare professionals, hospital risk managers

Smiths Medical and FDA notified healthcare professionals about a nationwide voluntary recall of Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm). A small number of tubes were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create the potential for the clinician to experience difficulty passing through or withdrawing the suction catheter. The health consequences that may result from use of the defective device include the inability to remove secretions from the device and from the patient's airway, which may result in partial or complete obstruction of the airway and an inability to ventilate the patient. In addition, this defect may increase airway resistance and compromise the ability to ventilate the patient. There is a reasonable probability of serious injury and/or death.

Tracheal Tube Recall - Press Release from Manfacturer

Smiths Medical is instructing customers to return all unused Tracheal Tubes and in their press release has provided recommendations for management of recalled product that is currently in use.

Read the complete MedWatch Safety summary, including a link to the firm's press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182084.htm


Posted by: DW AT 11:41 am   |  Permalink   |  Email
Wednesday, September 09 2009

Guidant POWERSAIL Coronary Dilatation Catheter Recall Due to Failures

Abbott and FDA notified healthcare professionals of the national Class 1 recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints that the distal shaft of the catheter exhibited damage. The damage may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

SEE: FDA Recalls Guidant POWERSAIL Coronary Dilatation Catheter Recall Update

 

Guidant POWERSAIL Coronary Dilatation Catheter Lawsuit - Talk to a Lawyer

If you or a loved one have suffered a serious injury or death as a result of the use or misuse of the above product, then please call us for a Free Confidential Case Consultation. Talk to a Board Certified Personal Injury Trial Lawyer with more than 25+ years of experience call 1-800-883-9858

Posted by: dw AT 05:44 pm   |  Permalink   |  Email
Wednesday, September 09 2009

Penumbra Neuron 5F Select Catheter Recall

Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.

Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

SEE: Catheter Recall - Penumbra Neuron 5F Select Catheter Recall and Penumbra 6F Neuron 070 Delivery Catheter Recall - Stroke & Death Lawsuits

Penumbra Neuron 5F Select Catheter Lawsuit - Talk to a Lawyer

If you or a loved one have suffered a serious injury, stroke or heart attack or you have lost a loved one, as a result of the use of a Penumbra Catheter, then please call us for a Free Confidential Case Consultation. Talk to a Board Certified Personal Injury Trial Lawyer with more than 25+ years of experience call 1-800-883-9858

Posted by: dw AT 05:29 pm   |  Permalink   |  Email
Willis Law Firm - Houston, Texas Drug Injury Lawyer and Attorney Free Lawsuit & Class Action Lawsuit Lawyer

 

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This is an Attorney / Lawyer Advertising Website. It is not a medical information, medical dictionary, medical advice or medical help site. Talk to you own treating Doctor about any questions or concerns that you have concerning any medicine, drug, medical device or treatment plan. Do not rely on any information on this site to alter, stop or change any medication or treatment plan by your prescribing or treating Doctor. Many of the drugs and devices listed here on this site have published risk and warnings associated with their use and have not been recalled. This website is not in anyway connected with any drug company or the FDA.Check with your Doctor, Pharmacy and/or the FDA as to any concerns as to their use, recall status and safety. See http://www.fda.gov/ for the latest information.

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