Vascular Solutions Recalls Some Langston V2 Dual Lumen Catheters Due to Defect

07092014On May 23, the Vascular Solutions company issued a voluntary nationwide recall of 40 lots of their Langston® V2 Dual Lumen Catheters. The company received two reports of incidents where the inner catheter separated from the hub during use, potentially entering the patient’s circulatory system. But in each report, the catheter was retrieved without injury.

The lots recalled were manufactured between January 2014 and April 2014 and included model numbers 5540 and 5550. Vascular Solutions estimates that a total of 8,580 of the recalled catheters were sold between March to May 2014 and approximately 3,847 were unused in the field as of July 3.

The recall includes the following lot numbers:

  • 569436-569437
  • 569962-569965
  • 570177-570178
  • 570337-570341
  • 570504-570507
  • 570592-570593
  • 570674-570675
  • 570744-570746
  • 570836
  • 570926-570929
  • 571099-571103
  • 571350
  • 571412-571415
  • 571727

Hospitals that received the catheters have been asked to cease use and return unused products to Vascular Solutions for replacement. At this time, 86 percent of the defective catheters have been accounted for and are in the process of being returned.

Although the company initiated the recall in May, the press release from Vascular Solutions did not go public until July 3, and the information was not published to the FDA medical device recall page until July 7. With an estimated 14 percent of the defective medical devices still potentially in use, there is still a chance of patient injury from these catheters.

As a patient you cannot guarantee the safety of the medical equipment your doctor uses. However, you can help reduce your risk of adverse reactions to medications and equipment by informing your doctor of any allergies or past complications with medical care. Remember, if anything seems unusual about the equipment used in your care, alert a staff member immediately.

Image courtesy Vascular Solutions

GM’s Faulty Ignition Recall

Defects, In The News

GM-HQ-300x198Car manufacturing company General Motors has recently come under fire for yet again recalling millions of vehicles for faulty parts. The most recent recall is for roughly 8.4 million vehicles to fix faulty ignition switches, including models made as far back as 1997. The latest recalls was brought on by three additional fatalities caused by the faulty switches. This latest recall makes a total of 28 million vehicles recalled by GM in the past year.

The models in GM’s latest recall have been connected to three fatalities, eight injuries and seven crashes. Their previous recall was brought on by the report that 13 fatalities had occurred due to GM’s faulty parts. In a statement made on Monday June 30, GM said the three latest deaths occurred in GM vehicles that were being recalled but it was unclear whether or not the ignition switches had been the cause of the accidents.

After receiving reports of faulty parts, GM released a statement that they underwent the most comprehensive safety review in the history of the company. GM CEO Mary Barra, who took on the role in early January just before GM disclosed the first round of recalls, has stated she plans to act immediately to any issues with any of their vehicles and keep the safety of GM customers as the top priority.

GM is working to compensate any and all affected by their recalls, even hiring victims’ compensation expert Kenneth Feinberg to calculate what is owed to each victim based on the number of those affected, each victim’s demographic (age, income, kids or no kids, marital status, etc), and how each victim was affected (death and/or injury and severity). Feinburg has stated that he knows no amount of money will ever cover the loss of a loved one, but at this point it is the most GM is able to do.

With approximately 28 million cars recalled in the last year, it is likely you or someone you know has been affected in some way. GM has released a document stating which vehicles and model years are being recalled. Anyone with a GM manufactured vehicle should carefully look over the document to ensure his or her car is not listed. To learn if your car is recalled, visit the GM recall center and type in your Vehicle Identification Number here: GM Recall VIN Tool. If GM notifies you that your car has been recalled, they will notify you when parts are available and to contact your nearest GM dealer to arrange a service appointment. GM is warning all drivers of affected vehicles to remove all items from their key rings in the meantime, including the key fob. Additionally, GM urges drivers to always check that an affected vehicle is in park, including setting the parking brake at all times.

If your vehicle is being recalled by GM and you have been in an accident due to the faulty part, contact the experienced DFW product liability attorneys of Reyes Browne Reilley immediately so we can ensure you take the right course of action to get what is owed to you by GM.

Cost Plus World Market Recalls Glass Bubble Knobs Due to Laceration Hazard

Defects, Products

Microsoft Word - CPWM Bubble Knobs Web Sign FINAL 5.30.14A recent product recall serves as a reminder that even mundane items like cabinet knobs can be hazardous if not properly manufactured. Cost Plus World Market is recalling 251,400 glass bubble knobs after five reports of injury.

Consumers who purchased the hazardous knobs reported that if the knobs break, they can become jagged pieces of glass which have caused hand and finger lacerations. No deaths have been reported and the company has issued a recall of the defective knobs. The knobs came in six colors (blue, pink, green, smoke, amethyst, and clear) and came in a 1.25-inch size and a 0.75-inch size.

There are three Cost Plus World Market stores in the Dallas area: Turtle Creek, Old Towne, and Galleria North. If you purchased a glass bubble knob at these stores between October 2010 and April 2014 you can return them to any World Market store for a full refund. If you were injured by a broken knob you should visit the Consumer Product Safety Commission’s (CPSC) website to report the incident.

Any consumer product can be potentially dangerous if manufacturers do not produce their goods following high safety standards and putting them through rigorous testing. If you notice a defect or danger while using a product you should report the problem to the CSPC immediately and also inform the product manufacturer. Defective products should be pulled from shelves immediately after a recall has been issued, as selling recalled goods is an illegal act that should be reported to the CPSC.

Image courtesy Cost Plus World Market

Food Allergies Cause Product Recalls at Easter


Shelled_pine_nutsFood allergies can cause severe reactions in some people, and can be extremely dangerous. This is one of the reasons that food products are required to list ingredients. In April 2014, several foods are being recalled due to ingredients not listed on the packaging.

Wegman’s Food Markets is recalling Easter bread, which contains eggs, not listed on the package. Unlisted eggs were also the cause of a recall of Mini Butter Croissants at Whole Foods. Egg allergies are common among children, and reactions can be dangerous.

Hickory Farms Farmstand Recipe Chipotle Ranch Sauce was recently found to contain milk that was not listed among ingredients declared on the label. Milk is also present in the White Bean Hummus produced and sold by Price Chopper. Lactose intolerance can cause millions of people to develop intestinal distress when they consume products containing milk.

AngelBowls Corkscrew Pasta and Creamy Tomato Vodka Sauce is being recalled due to the presence of pine nuts – a powerful allergen – in its recipe that is not listed on the package. That product is manufactured by Dominex Natural Foods.

Nut allergies are often severe, and can result in a life threatening reaction called anaphylaxis. Allergies to tree nuts of all varieties are one of the most common allergies in people of all ages. These adverse reactions often last a lifetime, although many other allergies come and go over the course of years or decades.

Johnson and Johnson Ordered To Pay Damages In Mesh Case

transvaginal-mesh-lawsuit-verdict-johnson-johnson-300x271Johnson & Johnson, a health-care company based in New Jersey, has been ordered to pay $1.2 million to Linda Batiste after a Texas jury ruled that its TVT-O mesh sling had a faulty design.

Produced by Johnson & Johnson’s Ethicon unit, the TVT-O vaginal mesh insert eroded in 64-year-old plaintiff, causing pelvic pain from infection and nerve damage. J&J faces over 12,000 mesh lawsuits – most of which are being heard by a federal judge in West Virginia.

Previously, advocacy group Corporate Action Network had petitioned Attorney General Eric Holder to look into allegations that J&J had tampered with evidence. They accused the company of destroying records that indicated research volunteers were injured during the testing of the product.

Regardless of how the tampering investigation turns out, the verdict returned in Linda Batiste v. Ethicon is a major victory for those injured by the defective TVT-O. It sets the precedent for future action against J&J.

Have you or a loved one been impacted by the TVT-O or another defective mesh product? If so, contact us now.

Graco Car Seat Recall


dreamstime_s_23682073-200x283A Graco car seat recall in February affected 3.8 million units of the protection devices for babies and toddlers. This decision by the company was made concerning the the construction of 11 of their 18 models of car seat.

The defective car seats were manufactured between 2009 and July 2013, according to the company. A spokesperson for the car seat producer said the affected buckle was changed on products manufactured in the second half of last year. This was the fourth-largest recall ever made of the devices.

Manufacturing problems centered around the buckle used to secure children in their seats. The button to unlatch the buckle can become stuck, making it difficult to remove the child in an emergency. Food or drink spilled in the mechanism can aggravate the problem.

Announcement of the voluntary recall was made by the National Highway Traffic Safety Administration.

“NHTSA’s investigation will remain open pending its evaluation of the Graco recall and until the agency’s consideration of the review of the 7 remaining sea models is completed,” the agency reported.

Graco has agreed to replace all faulty buckles with the new design, at no cost to parents.

“This does not, in any way, affect the performance of the car seat or the effectiveness of the buckle to restrain a child,” the company told its customers.

The NHTSA is recommending that parents find a different car seat to use while waiting for the replacement part to come in from Graco.

Does Cheap Equal Dangerous in Small Cars?


Suzuki-Maruti-Alto-crash-test-032314Small cars are great on gas, and can be fun to ride, but are they safe in accidents?

Independent crash tests were preformed on a number of small, inexpensive cars, including the Tata Nano. This vehicle, billed as the “best mileage small car in India,” may also be among the most dangerous.

Several models of car were tested in front-end crashes, including the Tata Nano. Also tested were the Suzuki-Maruti Alto 800, Ford Figo, Hyundai i10, and Volkswagen Polo. Each model of economy car was subjected to independent crash tests by Global NCAP, a non-profit organization based in England. The Alto 800 is the best selling car in India.

Test car crashes took place at 40 miles per hour. The Tat Nano received zero stars from judges. This signified a significant risk of deadly impacts for people riding in the car. In test crashes, the body of the car collapsed. Similar results were recorded for the Hyundai and Suzuki models. Volkswagen and Ford did slightly better in the tests.

“India is now a major global market and production center for small cars, so it’s worrying to see levels of safety that are 20 years behind the five-star standards now common in Europe and North America. Poor structural integrity and the absence of air bags are putting the lives of Indian consumers at risk,” Max Mosley, chairman of Global NCAP, in a statement.

As far as automobile safety is concerned, bigger is better.

Recalled Kidney Dialysis Products Cause Heart Injuries


reyes-blog-0205131-300x199Chronic kidney failure may be due to diabetes or low blood sugar, and affects approximately 2 million people. In the US, kidney disease affects over 2 out of every 1,000 people. In kidney dialysis, a machine called a dialyzer uses a solution to clean the blood. Products used in this process were GranuFlo and NaturaLyte, which may produce an excess of bicarbonate leading to a condition known as metabolic alkalosis in which pH levels in the body are elevated. This condition can cause low blood pressure, heart attacks, serious heart injuries and sudden cardiac-related deaths.

GranuFlo and NaturaLyte are manufactured and marketed by Fresenius Medical Care (FMC). IN 2011, Fresenius had a whopping net revenue of $12.8 billion and is the US leader in the dialysis market. FMC also owns over 1,800 U.S. Dialysis clinics that perform these treatments with GranuFlo. Additionally, approximately 125,000 patients are treated with GranuFlo at other clinics.

At the present time, Fresenius Medical Care has numerous suits against it since 941 patients suffered from cardiac arrest in 2010 after being treated with GranuFlo products. In March of 2012, the FDA recalled both GranuFlo and NaturaLyte. Unfortunately, this recall came far too late to save countless patients who experienced severe symptoms or died from these products. Worst of all, patients or survivors of loved ones who died say they were not informed of the dangers of using GranuFlo or NaturaLyte.