Scientific Protein Laboratories LLC (SPL) manufactures Heparin Sodium USP active pharmaceutical ingredient that is used by B. Braun Medical Inc. to produce Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride injection solution
Click Here To Contact Us For A FreeCase Evaluation
nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The recall affects the following 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.
B. Braun FP Lot # B. Braun FP Material Description NDC Numbers CAN DIN
J7D490 P5872 Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A
J7C684 P5771 Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A
J7D496 P5771 Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A
J7C470 P5872 Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A
J7D580 P5671-00 Heparin Sodium 20,000 Units in 5% Dextrose Injection (500mL) N/A 02209713
J7E420 P5872-00 Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) N/A 02209721
J7C611 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7C557 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7C477 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7C705 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7D485 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7E415 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7E416 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7E494 P5872 Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A
J7E500 P5771 Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A
J7E577 P5771-00 Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) N/A 01935941
J7E489 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7N556 P5872 Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A
J7P404 P5771 Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A
J7N604 P5771 Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL) 0264-9577-10 N/A
J7P476 P5872 Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL) 0264-9587-20 N/A
J7N519 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
J7N676 P8721 Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL) 0264-9872-10 01935933
Click Here To Contact Us For A FreeCase Evaluation
B. Braun Medical Inc. began recalling the lots on March 21, 2008. This product recall was initiated due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant.
Click Here To Contact Us For A FreeCase Evaluation
The Food and Drug Administration has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.
Heparin Lawyer Class Action Lawsuit Attorney Website

Federal regulators may have found that the contaminated heparin linked to 19 deaths was caused by a Chinese counterfeit that was much cheaper than the actual heparin to produce. The counterfeit substance, believed to be a chemically altered form of chondroitin sulfate, was introduced into the contaminated heparin batch that led to the heparin recall a few weeks ago. It is not known if the counterfeit substitution was intentional or by accident. If intentional, the motives behind such a counterfeit addition are also not known. This leads me to conclude that exporting drugs, especially from places like China is highly uncertain and potentially dangerous. Regulations and monitoring of manufacturing and quality control practices are at best not known.

13 million people, primarily women, suffer from urinary incontinence. The Mentor ObTape Vaginal Sling transobturator device was designed to replace weakened or ineffective muscles in the urethra that control urination. The Mentor ObTape Vaginal Sling was supposed to be the mimimally invasive cure for this medical problem. However, 17-18% of women who’ve had this sling implanted have experience such complications as vaginal extrusion and urinary tract erosion, extreme vaginal pain, vaginal discharge, and infections. The non-woven design of the Mentor ObTape Vaginal Sling obstructs oxygen and nutrients. The vaginal sling was introduced to the marketplace in 2003. Within three years, the medical device was removed due to serious medical complications as well as its ineffectiveness in treating urinary incontinence. Many of the women who’ve had this device implanted and subsequently removed have experienced crippling pain, vaginal scarring and no relief from the original problem of incontinence.

Accidentes automovilísticos continúan siendo la causa principal de muerte para Americanos menores de 34 años. Cada año, 40,000 personas pierdan sus vidas en choques de autos. Los resultados psicolólogicos, economicos, y físicos causan un tremendo impacto tanto en familias como en individuos. Los resultados pueden ser una pesadilla cuando se afrontan tratamientos médicos, reparos del auto, facturas médicas, pérdida de trabajo, y de dinero. Sin embargo, las decisiones que se hacen durante este periodo pueden dejar un fuerte impacto tanto para individuo como la familia.
Qué hacer en caso de un accidente de auto?
1) Para
La ley de Florida require que el chofer de un auto involucrado en un accidente debe parar de inmediato en la escena sin bloquear el tráfico.
2) Proteja la escena del accidente
Los autos deben de ser dejados donde estuvieron en el momento del accidente si no están bloqueando el tráfico. Si tiene que mover su auto, deje notar la posición original de los autos involucrados en el accidente.
3) Notifique a los autoridades- tiene que contactar a la policia sobre el accidente, aunque nadie este aparentemente lastimado. Si el otro chofer dice que pagará por los daños de los autos, no tiene garantía. Es muy importante asegurarse que el reporte sea llenado.
4)No haga commentarios-con la excepción de intercambiar información, no debe commentar sobre el accidente, a menos que lo haga con la policia. Mantenga sus notas y opiniones para su mismo. No admita culpa. Eso le puede causar problemas en el futuro. No diga que se encuentra bien. Aunque ud. se sienta bien en este momento, ud. puede sentir malestar más adelante.
5. SEGUROS DE AUTO Y COBERTURAS:
Bajo su póliza de seguro, Ud. tendrá que notificar el accidente a su compañía aseguradora dentro de las 24 horas de ocurrido el accidente. Su compañía le pedirá un reporte con los detalles del accidente. Bajo el contrato de seguros Ud. está obligado a cooperar con su compañía de seguros en la investigación de su caso sin embargo no se requiere un testimonio grabado.
UD. NO ESTA OBLIGADO BAJO NINGUNA CIRCUNSTANCIA A DAR UN TESTIMONIO GRABADO A LA COMPANIA ASEGURADORA DEL OTRO CHOFER ES MAS NUNCA SE DEBERA HACER ESO. Por lo tanto si la otra compañía le pide grabar el testimonio su respuesta debe ser NO, solamente debe dar detalles en forma verbal y no diga QUE SE SIENTE BIEN, pues su condición puede cambiar en el transcurso de los siguientes días. No discuta mayores detalles hasta que consulte con un abogado.
COBERTURA DE NO CULPA
El estado de Florida es un estado NO-CULPA, aunque Ud. No haya provocado el accidente, su compañía de seguros será responsable de sus gastos médicos. Bajo la ley de la Florida, su compañía (Personal Injury Protection o PIP) pagara 80% de todos los gastos razonable de asistencia médica y tratamientos menos el deducible que Ud. haya adquirido en su póliza.
COBERTURA DE NO CULPA: SALARIOS
Su PIP pagara el 60% de cualquier salario perdido como consecuencia del accidente (nuevamente, menos el deducible adquirido en su póliza) Para recuperar salarios perdidos su médico tratante tiene que indicar que Ud. no puede trabajar. Su medico deberá elaborar una declaración de la inhabilidad indicando el periodo que el considera razonable de acuerdo a sus lesiones físicas. Durante este periodo Ud. es elegible para recibir el pago de salarios perdidos. RECUERDE que Ud. es responsable de los impuestos generados sobre los salarios pagados durante este periodo.
PAGOS MEDICOS
Esta cobertura médica, conocida también como MED Pay, es opcional. También puede ser aplicado a sus cuentas médicas y puede cubrir deducibles que Ud. tenga. Pagará el otro 20% de su tratamiento no cubierto por PIP y pagará 100% de los costos del tratamiento médico hasta el límite de su MED Pay, una vez que su PIP se haya agotado. (Significa que Ud. no tiene beneficios restantes de PIP)
DAÑOS MATERIALES
Si Ud. fue el causante del accidente, el conductor del otro auto no puede forzarle a pagar por daños materiales sin procesos jurídicos. Ud. tiene que notificar el accidente a su compañía aseguradora. Si omite notificar a su compañía esto le puede causar omisión de contrato y por lo tanto su compañía de seguros puede rechazar los pagos de daños materiales del otro conductor. Si Ud. NO fue el causante del accidente y tiene cobertura comprensiva y de colisión en su póliza, y si su auto es reparable, Ud. tiene dos opciones: Ud. puede pasar los gastos con su propia compañía o con la compañía de seguros del otro conductor.
Hay ventajas en cada opción:
• Si Ud. opta por su propia compañía de seguros, siendo Ud. el asegurado le dará ventaja a tramitar su demanda rápidamente. Sin embargo Ud. será responsable del deducible y tendrá que pagarlo por adelantado. Su compañía podrá recuperar el gasto, pero puede tomar algún tiempo.
• Si Ud. opta por la compañía de seguros del otro conductor (causante del accidente), ya que Ud. no es el asegurado puede que le tome mas tiempo para procesar la demanda, sin embargo no tendrá que pagar gastos de deducibles o reparación.
SEGURO Y COBERTURA
LOS DAÑOS MATERIALES – PERDIDA TOTAL Si su auto ha sido totalmente dañado Ud. tiene nuevamente dos opciones:
Ud. puede pasar los gastos con su propia compañía o con la compañía de seguros del otro conductor.
Es recomendable que obtenga ofertas de las dos compañías aseguradoras, ya que una le puede valorizar su auto por mayor cantidad de dinero. Por ejemplo su propia compañía puede valorizar su auto en $ 2,750.00, mientras que la compañía del otro conductor lo puede valorizar en $2,500.00. Bajo este ejemplo, Ud. recibirá inicialmente $2,250.00 de su propia compañía (asumiendo que Ud. tiene $500.00 deducible) Su compañía aseguradora recuperará el deducible y se lo devolverá a Ud. Por lo tanto Ud. recibirá mayor cantidad con su propia compañía aseguradora.
Nunca discuta valorizaciones con su portador de seguro o viceversa ya que se puede prestar a elevar o disminuir la valorización como convenga. Además es una buena idea si Ud. mismo hace sus propias investigaciones tanto en las páginas del Internet NADA, Edmunds y Libro Azul de Kelly para determinar el precio de su auto.

An interesting debate is brewing among healthcare professionals and medical device manufacturers over the ability to re-use devices that are labeled as single use. Hospitals say that reusing medical devices such as scissors, scrubs, and sharp saws saves money and is safe because the devices are sent away for sterilization. The companies that perfom these sterilization processes argue that once cleaned these medical devices are as good as new. The Government Accountability Office agrees with them. However, the medical device manufacturers, who stand to lose money from such recycling, are not so certain. At this point, it’s not clear which group is correct.

Medtronic’s AneuRx stent-graft system has had a higher death rate than conventional surgical options, according to the FDA, which posted its findings on its website. The stent is designed to treat abdominal aortic aneurysms, a potentially life-threatening condition in which the aortic artery bulges and can burst resulting in death. This latest FDA warning comes on the heels of Medtronic’s Sprint Fidelis cardiac defibrillators whose leads have been found to fracture causing electrical shorts. The culprit in the Fidelis defibrillators is the leads which are thin wires that send electrical impulses to the heart regulating the cardiac rhythm.

Kava, the Polynesian herbal supplement, has made its way into health food stores and vitamin outlets in Idaho. While Kava has been touted for its tranquilizing qualities by its supporters, the FDA and other medical professionals have warned that it can lead to liver toxicity and even death. Great Britain banned kava from store shelves and Germany and Switzerland have restricted its usage due to liver problems. In March 2002, the FDA issued a consumer advisory concerning the potential for liver damage to those using Kava Kava and Kava Kava-containing products have been associated with liver-related injuries – including hepatitis, cirrhosis, and liver failure — in over 25 reports of adverse events in other countries. Four patients required liver transplants.
Kava Kava Lawyer Consumer Justice Website

A federal investigation into the relationship between medical device companies such as knee and hip replacement manufacturers and the orthopedic surgeons who use these devices has revealed a murky, ethically challenging, and sometimes illegal relationship between the two. Four of the world’s largest medical device manufacturers got caught up in this investigation and agreed to pay $131 million to settle the federal probe. The companies included Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc., and Smith & Nephew Inc. A fifth company, Stryker Corporation, cooperated with the federal government and was able to avoid paying fines. However, just last month Stryker received a subpoena from the criminal division of the Justice Department regarding possible bribes to foreign officials in violation of the Foreign Corrupt Practices Act. Stryker’s problems are not solely the criminal probes. Stryker had to recall its Trident PSL and Trident Hemispherical Acetabular Cups used in hip replacement surgery. The recall came one week after the FDA issued a warning letter about manufacturing defects in Stryker’s New Jersey plant.
When doctors are receiving fees for choosing a particular medical device the ethical lines become very blurry quite quickly. This is what prompted the federal probe. Doctors have an ethical duty to pursue what is best for the patient regardless of his/her “consulting relationship with a medical device company. If doctors receive consulting fees with companies who make the devices the doctors are using to implant in patients that relationship must be monitored and evaluated. “Although many of these payments were for legitimate services, others were not,” Gregory E. Demske, assistant inspector general for the U.S. Department of Health and Human Services, told a Senate panel last month.

Amgen and Wyeth have added the black box warning to the arthritis drug Enbrel after the drug has been linked to infections including tuberculosis. Enbrel is designed to work by soaking up an inflammatory protein called TNF. Enbrel had already had a bold warning placed on its prescribing label. The black box warning label will be the most serious warning issued by the FDA. Other arthritis drugs such as Vioxx have run into trouble in the last few years because of a link to heart attacks. Enbrel appears to have no such issue. However, the link to infections, especially tuberculosis warranted the black box warning label.

Listeria monocytogenes, an organism that is capable of causing serious and sometimes fatal infections in those with weakened immune systems, the very young and the elderly is the culprit for the latest food recall. Slade Gorton & Co. has recalled its ICYBAY langostinos because the ready to eat food product may be contaminated with the listeria monocytogenes. The product retails in one pound, clear plastic package marked with UPC 0-73129-61672-8 on the top and with an expiration date of June 2009 and is distributed under the brand name of “ICYBAY”. The product also was distributed to wholesale accounts, also under the “ICYBAY” brand, in five pound clear plastic packages containing either 70-90 count, 90-125 count or 120-150 count. This recall involves production dates of July 18, 2007 through August 13, 2007 and/or Julian dates of 199 through 232.