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October 4, 2016: Flush Syringes B. Cepacia Infection Link – Nurse Assist, Inc. Announces Recall

Flush Syringes B. Cepacia Infection Link Announced – October 4, 2016, Nurse Assist, Inc. announced that the company is recalling all unexpired lots of its I.V. Flush Syringes because the products may be linked to a multi-state Burkholderia cepacia outbreak. The U.S. Centers for Disease Control and Prevention (CDC), indicated that B. cepacia poses little medical risk to healthy people; however, people who have certain health problems, such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to B. cepacia infection. B. cepacia is a known cause of infections in hospitalized patients.

Flush Syringes B. Cepacia Infections – Product Recall Information

According to a Nurse Assist company press release, the recall affects the following flush syringe lots and part numbers:

  • Product Code: 1203; Product Description: IV Flush Syringe, 3ml fill; Lot Number: All unexpired lots
  • Product Code: 1205; Product Description: IV Flush Syringe, 5ml fill; Lot Number: All unexpired lots
  • Product Code: 1210; Product Description: IV Flush Syringe, 10ml fill; Lot Number: All unexpired lots
  • Product Code: 1210-BP; Product Description: IV Flush Syringe, 10ml fill; Lot Number: All unexpired lots

Product Numbers 1203, 1205, and 1210 are packaged 30 syringes to an inner carton and six inner cartons in a case (180 syringes). For product number 1210-BP, 100 syringes are packaged in an inner carton with four inner cartons in a case (400 syringes). Lot code information can be found on the outer case panel, the back panel of the inner carton, and on each syringe label.

The lots being recalled were distributed to customers and distributors between 02/16/16 and 09/30/16. Product can be identified by the labeling on the packaging and device. Nurse Assist is directing customers not to use the product from recalled lots.”

Nurse Assist advises that facilities should discontinue using the recalled product and return it to the supplier stating “Nurse Assist is actively investigating the possible link to the infections with the Food and Drug Administration, the U.S. Centers for Disease Control, and various state health departments to ensure that the products are safe for their intended use. Until an investigation can be completed, Nurse Assist urges all healthcare facilities with affected product to discontinue use and return the product to the supplier.” Facilities can contact the Customer Service Team at 1-800-649-6800 ext. 10.

Call The Weinberg Law Firm For B. Cepacia Lawsuit Information

Please see Personal Injury Lawyer NJ to learn about The Weinberg Law Firm. Attorney Eric Weinberg has assisted personal injury victims since 1984. Focusing primarily on pharmaceutical drug and medical device litigation, our firm has obtained over 800 million on behalf of clients. If you have questions regarding a potential Burkholderia cepacia infection lawsuit related to this product recall or a Docusate Lawsuit, please call our law firm at 1-877-934-6274. Our phones are answered 24/7.

August 19, 2016: Honeywell Eyewash Recall Announced Due To Potential Klebsiella Contamination

Honeywell Eyewash Recall Announcement – Honeywell announced a recall for one production lot of 32-ounce bottles of Eyesaline Eyewash solution because the product may be contaminated with Klebsiella pneumonia bacteria. The recalled eyewash is used for emergency eye rinsing following an injury.

About Klebsiella

According to the U.S. Centers for Disease Control and Prevention (CDC) Klebsiella is a type of “bacteria that can cause different types of healthcare-associated infections, including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis.” Although Klebsiella can be found in the intestines of healthy individuals, it can cause infections in the frail or in individuals who are exposed to the bacteria as the result of certain medical procedures or products. For example, a patient can be exposed to the bacteria via contaminated medical products including ventilators or iv catheters; person-to-person by the contaminated hands of healthcare workers; and/or environmental contamination.

Honeywell Eyewash Recall Information

A company press release provided the following Honeywell eyewash recall information :

“Eyesaline Eyewash is sold through industrial sales distributors. Approximately 9,700 32-ounce bottles with lot number F16091-61 are subject to recall. No other lot number of the product is subject to this recall.

Distributors must stop distribution of the affected product and return it to Honeywell for credit or replacement. Commercial-industrial users of the product should also check whether their Eyesaline Eyewash is subject to recall. If it is, customers should stop using the solution and contact their distributor for replacement or credit.

The affected product and lot number can be identified as follows:

• Product: 32 ounce Eyesaline Eyewash
• Lot number: F16091-61 (no other lot number is subject to recall)
• The lot number can be found on the outside of the product case, shown at left, and on individual bottles, as shown on the right below.”

Contact The Weinberg Law Firm For Consumer Product Lawsuit Help

To learn more about our law firm, please see Personal Injury Lawyer Middlesex County NJ. Since 1984, Attorney Eric Weinberg has assisted product liability victims including those injured by defective consumer products, medical devices, and pharmaceutical drugs. We are ready to help you too. For a free legal case evaluation please call us toll free at 877-934-6274. You can learn more about our practice at Personal Injury Lawyer New Brunswick NJ.

July 11, 2016: Alere to Initiate Withdrawal of the Faulty Blood-Thinner Monitor

Faulty Blood-Thinner Monitor

Announcement Regarding Faulty Blood-Thinner Monitor

Alere Inc. will be withdrawing from the market the blood-thinner monitor, Alere INRatio® and INRatio®2 PT/INR Monitoring System, because the device may potentially show inaccurate results.

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If you are a loved one has been seriously injured by a medical device, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form” found on this page, or contact us toll free at 1-877-934-6274 for a free legal case evaluation.

Blood-Thinner Monitor

This product is used to measure levels of blood-thinning medicines in the user. Blood-thinning medications are used to slow blood clotting, preventing complications like blood clots forming on artificial valves, valve obstruction and blood clots traveling to the brain and causing stroke.

In association with the U.S. Food and Drug Administration (FDA), Alere is determining when product discontinuation should occur.
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Recall of Faulty Blood-Thinner Monitor

According to the Press Release publicized by the FDA, in December 2014, Alere initiated a correction to inform users of the blood-thinner monitor that patients with certain medical conditions should not be tested with the system.

In the intervening time since this correction, Alere conducted research which they claimed had addressed the instances in which their blood-thinner monitor displayed inaccurate results due to faulty software.

The FDA, however, did not find this research to “adequately demonstrate the effectiveness of the software modification”. Due to this lack of evidence, Alere, at the recommendation of the FDA, removed the blood-thinner monitor from the market.

MEDICAL DEVICE LAWSUIT HELP

The personal injury lawyers at The Weinberg Law Firm is currently assisting individuals injured by medical devices, including vaginal mesh, power morcellators, IVC filters, and endoscopes/duodenoscopes as well as other devices. Mr. Weinberg also serves as local counsel for mesh lawsuits filed against manufacturers C.R. Bard and Johnson & Johnson consolidated in New Jersey Superior Court in Bergen County.

June 29, 2016: HeartWare Recalls Ventricular Assist Device Batteries – Premature Power Depletion

HeartWare Recalls Ventricular Assist Device Batteries

HeartWare Recall – The Issue

On June 29, 2016, HeartWare Inc. recalled the batteries for their Heartware Ventricular Assist Device because the batteries contain faulty cells that may cause the device to lose power prematurely.

The U.S Food and Drug Administration (FDA) provided the following battery recall information in a June 29, 2016 News Release.

If the battery of the HeartWare Ventricular Assist Device system is not connected to an additional power source shortly after the system sounds an alarm indicating a low battery level, the pump will stop working and the patient may experience serious adverse health consequences, including death.

BACKGROUND:

The HeartWare Ventricular Assist Device is used to deliver blood from the heart to the rest of the body in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant.

The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump.
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Recalled Product:

Batteries used on HeartWare Ventricular Assist Device (HVAD)

  • Serial numbers: BAT000001 to BAT199999
  • Model number: 1650
  • Manufacturing dates: May 19, 2013 to July 1, 2015
  • Distribution dates: May 21, 2013 to July 31, 2015
  • Devices recalled in the U.S.: 18,631 units nationwide, including Washington D.C.

Obtain A Free Personal Injury Lawsuit Evaluation From The Weinberg Law Firm

Please see Personal Injury Lawyer NJ to learn more about our legal services. If you are a loved one has been seriously injured by a medical device, and you have a question concerning your legal rights, please call us toll free at 1-877-934-6274 for a free legal case evaluation.

Please see Environmental Lawyer NJ and Talcum Powder Lawsuit for information regarding our legal services.

January 5, 2016: FDA Recommends Hospitals Desist Usage of Customed Surgical Packs and Trays

Customed Surgical Packs and Trays

The U.S. Food and Drug Administration (FDA) issued a Safety Communication cautioning hospitals and health care facilities in Puerto Rico to desist using Customed, Inc. Surgical Convenience Packs and Trays. The FDA asks these facilities to avoid these products due to unassured “integrity, safety, and efficacy”. Specifically, the FDA has not been able to test:

    • The sterility of the products,
    • That endotoxin and ethylene oxide levels are within safe limits,
    • That package integrity can withstand stresses during transport, and
    • That the products will be effective up to their expiration dates.

Customed Surgical Packs and Trays

The Surgical Convenience Packs and Trays manufactured by Customed, Inc are used during any surgical procedure, and include many surgical tools and assist items. The packs include exam gloves, absorbent towels, suture bags, surgical table covers and drapes. The trays include odium chloride irrigation bottles, catheters, needles and syringes.

Obtain a Free Medical Device Lawsuit Evaluation

If you are a loved one has been seriously injured by Customed Surgical Packs and Trays or any medical device, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form”, or contact us toll free at 1-877-934-6274 for a free legal case evaluation.

Customed, Inc

This product had been recalled June 2014, and again in October 2014. In November 2014, however, Customed, Inc resumed manufacturing tray and packs without informing the FDA. When the product was inspected again in April 2015, the product was again found to be inadequate in several safety and efficacy tests. Due to this failure as well as lack of inspection, the FDA highly recommended that health care professionals discontinue use of this product.

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Medical Device
Lawsuit News

Flush Syringes B. Cepacia Infection Link Announced – October 4, Read More

Honeywell Eyewash Recall Announcement – Honeywell announced a recall for Read More

Faulty Blood-Thinner Monitor Announcement Regarding Faulty Blood-Thinner Monitor Alere Inc. Read More

HeartWare Recalls Ventricular Assist Device Batteries HeartWare Recall – The Read More

Customed Surgical Packs and Trays The U.S. Food and Drug Read More

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