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Consultation is Free
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(732-214-1800)
Legal and Medical News Blog

Caramel Apples Listeria Monocytogenes Contamination

The Food and Drug Administration is notifying healthcare professionals and their medical care organizations of the ongoing investigation of an outbreak of listeriosis linked to commercially-produced, prepackaged caramel apples.

The CDC reports that  29 people in 10 states have been reported as being infected with the outbreak strains of Listeria monocytogenes, with all 29  ill people hospitalized and  five deaths reported. Nine illnesses were pregnancy-related.

Listeriosis can be fatal, especially in certain high-risk groups. These groups include the elderly, and people with weakened immune systems and certain chronic medical conditions such as cancer. FDA and state investigators are working to identify the source of contamination and to determine what products may be contaminated.

Consumers are advised not to eat commercially prepackaged caramel apples.  Anyone who experiences fever and muscle aches, sometimes preceded by diarrhea or other gastrointestinal symptoms, or develops fever and chills after eating commercially-produced, prepackaged caramel apples should seek medical care and tell the health care provider about any history of eating those caramel apples.

For more information, go to the FDA.

White and Blue Lion Tattoo Kits Recalled

The FDA is notifying health professionals and their patients of the voluntary recall of White and Blue-branded tattoo inks and needles due to confirmed bacterial contamination in unopened bottles of inks and on needles included in tattoo kits. The FDA is concerned that consumers are continuing to use contaminated inks for tattoos. Similarly packaged tattoo products remain available online and may be marketed by other distributors from the same manufacturer.

Injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo that can spread throughout the body through blood. Symptoms of illness include redness, swelling, itching, or blemishes in the tattoo, or pain in the tattoo that does not go away.These infections can be severe and require extensive treatment with antibiotics, hospitalization, or surgery. Sepsis, a potentially life-threatening body-wide infection of the blood, may result. Once the infection has healed, the area may remain permanently scarred. Anyone receiving a tattoo is at risk for infection, but particularly vulnerable are those with pre-existing heart or circulatory disease, diabetes, or patients with compromised immune systems.

RECOMMENDATION: The FDA is warning consumers not to use tattoo inks and tattoo kits that have been recalled or that have similar packaging to those that have been recalled. Consumers who purchase tattoo inks or who seek tattooing should examine the ink bottles and determine whether the inks and/or kits are part of the recall.

Read more at The FDA.

Six Deaths Linked to Nap Nanny Recliner

The tragedy around the Nap Nanny Recliner continues as  the U.S. Consumer Product Safety Commission confirms a sixth baby has died while in the product. The federal agency is urging parents to stop using the product and throw it away.

The latest death, which occurred in Hopatcong, NJ, involved an 8-month-old girl who was secured by the seat’s belt and found partly hanging over the side of the Nap Nanny recliner, trapped between the product and a crib bumper.  The Nap Nanny, which was manufactured by now defunct Baby Matters LLC, has been at the center of a massive recall and lawsuit, beginning in 2010, after five infant deaths were attributed to the product.

The CPSC reports that the six infant deaths linked to the recliner occurred in either two ways: either the baby partly falls or hangs over the side of a Nap Nanny and gets trapped between the product and crib bumpers; or the baby suffocates on the inside of the Nap Nanny.

In December 2012, the  CPSC took the unusual step of filing a lawsuit against the company  when investigators felt the company did not do enough to make its product safe for small children. The lawsuit was dropped after the parties reached a settlement  requiring the company to voluntarily recall the product.

For more, go to ABC News.

FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids

Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.

It is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

The FDA recommends that health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids, and directs that providers not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.

GM Car Owners Bringing Class Action in NJ

Last Monday, Plaintiffs filed a putative class action against General Motors in Trenton federal court. GM has issued a massive recall because ignition switches on multiple GM brands allowed the key to turn into the “off” position while the car was in motion, causing the engine to shutdown, and deactivating the power steering, antilock brakes, and airbag deployment. The faulty ignition has led to at least 13 deaths – although that number could be significantly higher – and numerous accidents and injuries.

The Complaint alleges that GM engineers first learned of the ignition problem in 2001, but did nothing until issuing a bulletin to dealers in 2005, and the eventual recall in February 2014. In the meantime, General Motors continued to build cars  with the defective ignition.  GM models up to model year 2010 are affected. The named plaintiff, Lisa Ruff of Hazlet, alleges that her daughter totaled  a  2007 Chevrolet Cobalt when the engine shut off, she  lost control, and struck a tree.

The judicial panel on multi district litigation has received notice of at least  15 other cases being filed against GM over the same issue, 8 of which were filed in Los Angeles, CA. On May 29, the panel will consider whether to consolidate all cases in Los Angeles.

Playtex Breast Pump Recall

Playtex Manufacturing, Inc. announced a voluntary nationwide Playtex Breast Pump Recall of certain AC/DC power adapters that are used with the Playtex Nurser Deluxe Double Electric Breast Pump. The casing on some adapters may become loose and separate, resulting in a potential for electric shock.

Adapters in the Playtex Breast Pump Recall

The affected adapters were manufactured from November 2012 through July 2013. The product can be identified by product serial number (P12324-XXXX through P13205-XXXX). Alternatively, the product can be identified by adapter production code (1241 through 1324). The adapters were sold along with the Playtex Nurser Deluxe Double Electric Breast Pump. The adapters were not sold separately.

Consumers who have purchased an affected product should contact Playtex for a replacement by calling 1-888-207-1492 from 8 a.m. to 6 p.m. ET Monday through Friday or online at  www.playtexproducts.com.

Please go to the FDA Website for more information.

GE Healthcare Resuscitation Systems Recalled

The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. These recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in newborns (neonates), and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). This may cause death in neonates, particularly those who are critically ill. Preterm and low-birth weight babies are also at increased risk in terms of morbidity and mortality.

The following products are affected:

  • Giraffe Warmer with Resuscitation System
  • Panda Warmer with Resuscitation System
  • Giraffe Stand-Alone Infant Resuscitation System
  • Resuscitation System Upgrade Kits
  • Panda Freestanding with Resuscitation System

All users should cease use of these products and contact GE for further instructions.  The link to the FDA recall is here.

Recall of Trilogy Ventilator Models 100, 200 and 202 by Philips Respironics

Respironics, Inc., a Philips Healthcare business, announced a worldwide recall of approximately 600 Philips Respironics Trilogy Ventilators due to a potentially defective component on the Trilogy Ventilator power management board, which could affect the function of the device. If this issue is not corrected it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in severe patient harm.

This recall affects models 100, 200 and 202, shipped between December 31, 2013, and January 30, 2014. Countries where affected devices have been shipped include the United States, France, United Kingdom, Hong Kong, India, Italy, Korea, Kuwait, Netherlands, and Singapore.

Customers who have questions about the recall or require further information or support concerning this issue, may contact their local Philips Respironics representative via the Customer Care Center phone number:  1-800-345-6443, which is active 24/7.

Read the full press release for more details and instructions.

3.7 Million Graco Car Seats Recalled

In the largest such child car seat recall in history, Graco is voluntarily recalling 3.7 million car seats over a buckling issue.  The company is contesting a government request to recall an additional 1.8 million seats over a similar issue.  In a statement, Graco said the voluntary recall affects “harness buckles used on all toddler convertible car seats and harnessed booster seats manufactured from 2009 to July 2013.”  Graco fixed the problem on all car seats sold since July 2013.  Graco car seats sell for between $99 and $400, depending on the model.

Food or liquid in the buckle mechanism can make the seat more difficult to buckle over time, or cause the buckle to become stuck in the latched or unlatched position.  The children’s products company added that it was offering a “new and improved replacement harness buckle to affected customers at no cost.” People can obtain one by calling 800-345-4109 or emailing consumerservices@gracobaby.com.

In the meantime, parents may continue using the seat.  “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 said.

For more information, read this CNN story.

BMW and Volkswagen Issue Recalls

The  Los Angeles Times  reports that “BMW is recalling more than 76,000 sedans and SUVs to fix an issue with the passenger-side airbags, while Volkswagen is recalling about 66,000 vehicles.” The Times says that the BMW recall affects over 76,6000 3-Series and 5-Series models from 2006 and 2007 that “could potentially have a defective mat in the front passenger seat that could fail to tell the vehicle’s airbag system if and how to deploy in a crash.”

The Times also reports that Volkswagen has issued a pair of recalls involving 2009-2011 Tiguan SUVs, and Jetta Hybrid sedans from 2013 and 2014. According to the  National Highway Traffic Safety Administration, in  the Tiguans, “the housing for a fuse for the exterior lights could melt, causing the lights to stop working, increasing the likelihood of a crash.” Meanwhile, with the Jettas, “fluid used in the cars’ transmissions may be corrosive and result in an electrical short and failure of the transmission.”

If you have an affected model, you should contact your dealer.

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