Puerto Rico Medical Device Manufacturer Faces Largest FDA Recall Ever

Recently, the U.S. Food and Drug Administration (FDA) issued a recall of 233 medical devices in one of the largest one-day recall events in the agency’s history.

The recall, affecting products manufactured by Puerto Rico firm Customed, Inc., received a Class I designation, the organization’s most severe classification. While the vast majority of FDA recalls fall under the Class II category (indicating less deadly consequences), all the affected Customed devices had packaging flaws potentially leading to contamination and infection in patients.

To date, no patients have reported adverse effects from handling or using these items. However, with “several hundred thousand units” currently on the market, locating and eliminating the devices from medical facilities and homes has become a top priority for the FDA.

The Customed recall assumes the dubious distinction not only of being the FDA’s largest on record, but representing 9 times more affected products than its predecessor.

Hurt By a Recalled Product? Here’s What to Do

As the number of product recalls increases, it’s important to take proactive and reactive measures to ensure your and your family’s safety. Even those making an effort to stay apprised of recent recalls may suffer harm from a recently recalled product, or even from one not yet recalled. When this happens, consider taking action such as:

  • Obtaining medical care. Go immediately to an urgent-care or emergency facility to have a doctor evaluate and treat injuries. Be sure to tell the intake worker your injury may be related to a product.
  • Retain documentation. Take pictures of the injury, product, and any other pertinent details, and retain any paperwork related to medical or other expenses you might incur.
  • Contact a defective products attorney. As soon as possible after the injury, reach out to a D.C. personal injury lawyer with experience handling cases involving defective products. Whether the product involved has been recalled or not, you deserve to know whether you are entitled to compensation for your suffering.

Manufacturers have a responsibility to keep their customers safe. When a company breaks your trust, explore all your legal options.


It's not just medical devices that cause problems. Food products do, too. Check out Chicken Nugget Recall Sheds Light on Food Safety

Labor Day Driving Safety Tips

As the beginning of school approaches, so does Labor Day. This holiday provides a much-needed three-day weekend for many professionals and allows families and friends to gather for one last summer celebration.

Although Labor Day is an enjoyable occasion for millions of Americans, the weekend also presents heightened risks to drivers. According to AAA, about 29.2 million people expect to drive over the holiday weekend; a 4.3% increase over last year’s 28 million.

Increased traffic, aggressive driving, and DUI driving all contribute to higher collision rates. The National Safety Council reports about 400 deaths related to car crashes each Labor Day. However, drivers can take measures to ensure their safety and that of others.

Whether traveling locally, to work, or across several states, follow these safety tips to avoid becoming a Labor Day statistic:

1.    Get adequate rest. The night before driving long distances, make sure each individual who will be driving gets at least 8 hours of sleep.

2.    Take frequent pit stops. Although it may be tempting to drive nonstop for several hours to reach your destination more quickly, resist the urge. Every few hours, pull over to allow everyone in the car to stretch their legs, eat a snack, and find a restroom.

3.    Care for your car. Conduct routine maintenance, such as oil changes and tire rotations, before embarking on a road trip. Ask your mechanic for an inspection to ensure other issues don’t result in costly and inconvenient breakdowns.

4.    Pack an emergency kit. If your car doesn’t yet contain jumper cables, a jack, a spare tire, flares, a first aid kit, food rations, and other emergency essentials, use Labor Day travel as an opportunity to supply it with these items.

5.    Practice defensive driving. Especially when driving in unfamiliar areas, remain aware of the behaviors of other drivers. Keep safe speeds and maintain safe following distances, avoid weaving or swerving vehicles, and have a passenger call the authorities if you witness unsafe conditions.

If a Labor Day car accident has caused injury to you or a loved one, reach out to a D.C. personal injury attorney to discuss your legal options.

Do NOT leave your child in a hot car. Find out more about this disturbing practice by reading: Recent Child Car Deaths Highlight Need for Heightened Awareness

Hot Car Deaths, the Law, and a New Way to Prevent Them

Posted by: Salvatore J. Zambri, founding member and partner

Picture of Salvatore J. Zambri

Over the years, we have posted multiple times about the dangers of leaving children in hot cars: 

Because this tragic situation has gathered more media attention, a number of states have enacted laws addressing leaving children in hot cars, and the NHTSA has initiated a campaign entitled "Where's Baby? Look Before You Lock."

Amid the record sweltering heat of this summer, national attention has increased on parents leaving their children alone in unbearably hot vehicles. According to a 2009 article in The Washington Post, 60 percent of these cases are ones borne of “negligence,” subjecting the wrong-doers to criminal charges. The ongoing re-occurrence of these cases has even led to individuals videotaping themselves engaging in the “hot car challenge” to demonstrate just how dangerous it is to leave a child there. As the Post noted in 2013, “43 children died from vehicle-induced heat stroke.” So far, in 2014, the number is at just under 20, according to the National Highway Traffic Safety Administration (NHTSA).

Almost all states in the United States have neglect laws that apply to these cases, and “19 states address it directly.” Prosecutors are granted discretion to determine whether there was malice or whether an accidental mistake occurred. The punishments for parents or guardians are varied, especially if the child survives, but some severe cases have recently earned media attention.

In the Atlanta, Georgia area, CNN has extensively covered a case, in which a father was charged this summer with felony murder after his son died in his car on June 18. In 2013, according to USA Today, an Arizona father left his son in a car for three hours – as he spent time at a bar – and the child’s resulting death led to convictions of manslaughter and child abuse for the father, who was sentenced to four years in prison. Obviously, this is a serious issue. 

New laws have been enacted providing guidance to bystanders if they see a child alone in a hot car. USA Today noted recently that in Tennessee, a new law “allows someone to break into a car to rescue a child if they believe the child is in imminent danger.” Meanwhile, at the federal level, there has been pressure applied to Transportation Secretary Anthony Foxx to initiate federal research into technology to help parents remember not to leave kids in their cars. Foxx indicated recently he would embrace the NHTSA’s “Where’s Baby? Look Before You Lock” campaign.

Beyond state legislation and federal initiatives, individuals can take steps to prevent these incidents. “Parents and caregivers are the first line of defense against these needless tragedies,” Acting Traffic Safety Administrator David Friedman stresses, “but everyone in the community has a role to play.” Though there are commonly referenced methods to avoid leaving a child in a car, a new method a Florida newspaper highlighted may be the most effective to date. “If you are driving a child,” Melanie Payne of The Fort Meyers News-Press writes, “after you put them in a back seat…put your left shoe back there, too.” After all, it is unlikely an individual would forget his or her shoe before exiting a car.

If this method helps you remember not to leave a child in a hot car, use it or design a memory device of your own.  Please keep your children safe.

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6 Quick Tips for Back-to-School Safety

As fall approaches, students and their parents begin preparing for the new school year. Whether children feel excitement, dread, or nonchalance about going back to school, the season certainly presents a change of pace from the more relaxed days of summer.

Along with returning to school come a new set of safety risks for children of all ages. As families work to create new routines, keeping the health and well-being of children in mind helps mitigate the hazards posed by traffic, public spaces, other students, and other components of the educational experience.

Six ways parents can help their children stay healthy and secure during the next school year include:

1.    Bus safety. Students riding the bus should be aware of the proper entrance and exit methods, especially when crossing the street. Those waiting for the bus should always remain at least 6 feet from the curb.

2.    Walking or bicycling to school. Increased traffic means children on foot or bike must pay close attention to their surroundings. Remind students of the rules of the road, and practice the walk with those taking an unfamiliar route to a new school.

3.    Teen driving.
Licensed drivers are often eager to begin driving to school; however, parents should exercise judgment in providing this privilege. Invest in additional training before classes start if a teen showcases irresponsible driving behaviors.

4.    Ergonomic backpacks.
Heavy or poorly-designed backpacks often lead to back problems in children. Inspect children’s bags before they leave for school, and ensure they use both straps.

5.    Playground safety. Instruct children in safe playground practices. Talk to school administrators about hazardous or outdated playground structures.

6.    Bullying prevention.
Parents who discuss bullying with their children and address potential concerns with educators help eradicate this harmful practice.

As children return to school, they deserve to learn in a safe and conducive environment. Should the negligence or abuse of another individual compromise your child’s health or wellbeing, a DC child safety attorney can help you take legal recourse.

What steps will you take to keep students safe as they return to school?

For further reading:

For kids who bike: tips for safer biking

For kids still on vacation

Recent Child Car Deaths Highlight Need for Heightened Awareness

Parents across the United States are becoming more aware of the dangers of leaving children locked in hot cars. A recent Georgia case, in which a 22-month-old child died after remaining locked in a car while his father worked all day, has led to widespread outrage and concern.

The father claims he forgot his son was in the car when he arrived at work. The temperature climbed to 92 degrees that day, bringing the car’s interior temperature to up to 140 degrees. When he returned to his vehicle at the end of the day, the child had died. Law enforcement officials continue to examine evidence from the vehicle and cell phone and other belongings. Search histories from his computer reveal an apparent interest in living “child-free” and in how hot a car’s interior must be to kill a child, suggesting the father will likely face charges for his potentially intentional acts.

Although the vast majority of parents have no intention of harming their children, busy lifestyles and unfamiliarity with the risks to their children may lead to behaviors that inadvertently compromise child safety. To raise awareness about the dangers of hot cars and help parents and caregivers keep their children out of harm’s reach, the National Highway Traffic Safety Administration (NHTSA) has spearheaded a new campaign.

“Where’s Your Baby? Look Before You Lock” seeks to educate adults about the hazards of leaving children unattended in hot cars. Their internet and radio initiative provides tips such as:

•    Never leaving a child unattended in a vehicle

•    Checking the front and back of a car before locking it

•    Hiding car keys from children and keeping them from playing in cars

•    Arranging with daycare providers to call if a child never arrives

The rush to get to a destination on time – or the convenience of leaving a child in a car – is never worth the dangers to their life and health. If someone’s negligence has led to your child’s injury or death in a hot car, contact a DC personal injury attorney to seek justice for yourself and your child.

What precautions have you taken to keep your young children out of hot cars?

Related: "5 Tips to Keep Kids Safe on Vacation"

Chicken Nugget Recall Sheds Light on Food Safety

Earlier this month, Perdue issued a recall of over 15,000 pounds of frozen chicken nuggets after customers reported contaminated products.

The chicken nugget recall pertains to 8-ounce boxes of Applegate Naturals Chicken Nuggets, some of which allegedly contained small plastic particles. The company produced the nuggets on February 5, 2014, and they were marked to remain on shelves until the same date in 2015.

Although no consumers have reported illness or injury after ingesting the chicken nuggets, Perdue acted quickly to recall them from multiple retailers across the country. As of August 8, these products are no longer stocked in stores; however, they may still remain in individual homes.

In light of this recent recall, consumers may wonder what measures the FDA and food manufacturers take to keep unsafe foods off of store shelves, as well as what they can do to keep themselves and their families safe.

What to Do In Case of a Food Recall

A manufacturer may enact a food recall for a variety of reasons, usually due to evidence or reports it has received that a product that may cause illness in those who consume it. Contamination by a pathogen or allergen may be responsible. Or mislabeling can prompt a recall.

All types of foods can become contaminated, from fresh produce to frozen, processed foods. Consumers wishing to protect themselves from illness should regularly engage in safety measures such as:

•    Checking news and recall sites
. Watching and reading the news regularly exposes consumers to information about prominent food recalls. Foodsafety.gov also offers recall listings, phone alerts, and a widget to keep people apprised.

•    Throwing out or returning items in question. Read the recall information to find out whether you should discard a product or bring it back to the store for a refund.

•    Call the hotline.
Most manufacturers provide a hotline for questions or concerns regarding a recall.

Exposure to contaminated foods may seem inevitable, but paying close attention to and complying with recent recalls helps prevent illness.

If you or someone you know has become ill from eating contaminated food, a D.C. consumer safety attorney can help you hold the manufacturer accountable.

Curious to learn more about FDA standards? Check out: Doctor Contends 15 Dead in NECC Medication Contamination was Preventible and Predictable

5 Tips to Keep Kids Safe on Vacation

Going on a family vacation represents a time-honored tradition, resulting in a lifetime of happy memories to cherish. Taking one or more children along for the ride – whether in a car, plane, or cruise – means exponentially more fun for parents, along with more work.

Kids of all ages often engage in potentially dangerous activities in new places, where they may feel unfettered and free from normal safety considerations. While enjoying fun activities, parents should remain aware of their children’s whereabouts and actions and take preventative measures against potentially hazardous situations.

5 Ways for Parents to Protect Kids on Vacation

Whether the family embarks on a long car trip, visits an amusement park, or sets out on a sailing adventure, risks to life and limb could abound. Here are some key risk reduction practices:

1.    Car safety.
Buckle seat belts, reduce driver distractions, obtain adequate sleep, maintain low speeds, and take frequent breaks to reduce the potential for collisions.

2.    Monitoring swimming. Whether you're visiting a pool, lake, or ocean, an adult should always monitor young swimmers. Pay attention to swimmer’s advisories regarding riptides or undertow, and use flotation devices for kids who haven’t yet mastered their stroke.

3.    Boating precautions.
From canoes to yachts to cruises, boats are a popular component of many vacations. Keep children safe by outfitting them in life jackets, and advise them to stay away from the edge of the boat in choppy water. At least one adult on a boat should possess CPR training in case of water inhalation incidents.

4.    Public supervision.
To ensure kids don’t get lost (or end up in the wrong hands), keep them close by your side at all times and accompany them to restrooms.

5.    Ride safety. At amusement parks, adhere to height-to-ride guidelines and ensure operators affix safety restraints properly before the ride begins.

Keeping children safe on vacation may present addition challenges, but the result can be a joyous and memorable occasion for everyone involved.

If the actions of others caused injury during a vacation, contact a Washington, D.C. injury lawyer to discuss your potential legal case.



Drivers Beware: Virginia and Maryland Enacted New Laws July 1

On Tuesday, July 1, new laws regarding vehicles and their operation went into effect in Maryland and Virginia. These statutes range from financial and tax considerations to stiffer penalties for toll booth dodgers and those driving under the influence.

Although not all of these laws apply to all drivers, you should understand your new rights and responsibilities under these laws to avoid inadvertent violations and citations.

New laws in Maryland include:

•    Gas tax increase. The existing gas tax has risen by less than one cent per gallon, which will go towards upgrading Maryland transportation systems.

•    Electric vehicle tax credit. Individuals who purchase plug-in electric vehicles or recharging stations will receive a tax credit based on the size of the vehicle’s battery.

•    Toll booth enforcement. Drivers who proceed through toll booths without paying or attending a court date within 30 days of a notice will be designated as a “toll scofflaw,” subject to vehicle registration suspension.

In Virginia, drivers should become aware of several new statutes, such as:

•    Hybrid license tax repeal. Hybrid vehicle owners will no longer have to pay a $64 fee to register their vehicles and will receive refunds for taxes they’ve paid in the past.

•    Military reprieve
. Returning active military members now have 9 more days to acquire current vehicle safety inspection stickers than before.

    New DUI restriction. All convicted DUI drivers must now install interlock systems in their vehicles while under driving privilege restrictions.

•    Disability designations.
Individuals on the autism spectrum or with intellectual disabilities may add this to their license with a signed statement from their physician.

Obeying laws governing the safe and responsible operation of motor vehicles is the responsibility of every motorist. Familiarize yourself with these new statutes to remain safe and compliant.

Has another driver’s disregard for the law resulted in injury to you or a loved one? Contact a Washington D.C. automobile accident attorney to explore your legal recourse.

Tips for Surviving the War between Car and Bike Commuters

When it comes to city transportation, biking is a cheap and efficient way to get around. D.C. and other cities have been engaging in concerted efforts – such as adding bike lanes – to make commutes easier for cyclists. However, the relationship between bikers and motorists remains precarious at best and hostile at worst.

In the war between the two modes of transportation, neither side is without fault. So what’s a commuter to do? When drivers and bikers alike incorporate a few safety measures, it helps save lives and sanity.

How Bikers Can Keep Safe (and Avoid Infuriating Drivers)

While commuting, cyclists must remember they fall under the same rules as motorists. This may mean making changes to their cycling ethos, including:

•    Stopping at red lights. Unless bike commuters dismount and proceed through crosswalks in the same direction as pedestrian traffic, they must stop at red lights along with motor traffic.

•    Using hand signals. Bikers should learn and use hand signals to indicate when they are preparing to turn or brake.

•    Not impeding traffic. Vehicles (such as bicycles) traveling slowly should make every effort not to obstruct the normal flow of traffic. Staying in a bike lane, if available, is the best way to accomplish this.

How Drivers Can Be More Considerate

To play their part in the reconciliation between drivers and bikers, motorists may incorporate behaviors such as:

•    Paying closer attention.
Before backing out of driveways or making turns, check for cyclists as well as pedestrians.

•    Avoiding aggressive behavior. Most drivers wouldn’t bump or crowd another motor vehicle, and doing so to a cyclist is even more dangerous.

•    Respecting the bike lane.
When a city has dedicated one or more lanes to bike traffic, don’t use them to pass other drivers. Leave these lanes to their rightful owners.

Although a few outliers will likely always exist, when the majority of bikers and drivers do the right thing, the result is a safer and more efficient roadway.

Injured in a car-bike accident? Contact a Washington D.C. automobile accident attorney to discuss your case.

Inside the Ignition Switch that Launched the GM Recall

The new ignition switch GM created in the late 1990s was supposed to be less expensive, less flammable, and virtually foolproof. Defective product attorneys, and now the world, know that it sadly did not work very well.

Ray DeGiorgio, a switch engineer, was responsible for redesigning the switch’s electrical system. In addition to electrical problems, the switch also presented mechanical difficulties. It didn’t meet GM’s own requirements, such as how much force it withstood before rotating. Rather than taking time to fix the problem, DeGiorgio approved the switch, referring to it as the “switch from hell.”

Not long after its release onto the market, customer complaints began. Drivers of the Saturn Ion and Chevy Cobalt, the first vehicles to incorporate the switch, reported that their cars were stalling for no obvious reason. Engineers didn’t consider this a “safety issue,” arguing that drivers could still muscle their cars to safety without power steering.

However, what engineers failed to anticipate was that when engines stalled, airbags would also not deploy in case of an accident – endangering the lives of their already vulnerable customers. Amazingly, Wisconsin State Patrol Trooper Keith Young and a research group at Indiana University separately managed to link airbag failures to the malfunctioning ignitions when GM engineers didn’t – at least not until 2007.

This was when engineer John Sprague started tracking air bag malfunctions in the Cobalt. He had hypothesized that the ignition problems were preventing airbags from deploying, but also noticed that the phenomenon had stopped in 2007 and later model year vehicles.

Unbeknownst to Sprague, DeGiorgio had approved a change to the switch in 2006, increasing the force required for turning the key in the ignition. However, he failed to update the part number after the change, despite a GM protocol that required him to do so.

The change wasn’t discovered until a law firm compared X-rays of switches from two different model years and noticed the discrepancy.

Although the mysterious switch at the heart of the GM scandal may have been what disabled consumers’ cars, it was the negligence and dishonesty of GM engineers and other complicit individuals that led to at least 13 deaths and countless injuries.

Have you or a loved one been affected by a defective auto part from GM or another manufacturer? The Washington D.C. defective product attorneys at Regan Zambri & Long can help. Contact us at (202) 463-3030 to schedule your free consultation.