Archive for the Category Product Liability


Tracoe Mini Tracheostomy Tubes Recalled Due to Labeling Error

Tracoe Mini Three Millimeter Tracheostomy Tubes are being recalled by Bryan Medical because of a labeling error that could create an injury hazard.  Instead of the contents of the product including a neonatal tube, there’s a chance that it could actually contain a pediatric tube.  Although the inner diameters of these items are both supposed to be three millimeters, the full length of the pediatric tube is 4 mm longer and thus could harm an infant’s trachea, an issue that could prompt serious adversity.  The items, which were made available to medical personnel between April 9 and 12 of this year, should be sent back to Bryan Medical.  A new version of the product not suffering from the labeling error will be provided.

Click here for more about the recall.

FDA Explains Importance of Reporting Child Medical Device Adversity

The Food and Drug Administration has released a new report focused on stressing to parents the importance of reporting problems associated with their children’s medical devices.  The worry is that side effects might be inappropriately attributed to an illness or perhaps an associated medication.  The FDA thus wants parents to recognize that a medical device can create adversity as well.  Whether a device has an actual defect or is difficult to use, the more information the FDA has, the better they’re able to bolster safety around each device through regulatory efforts.  Parents are asked to take into consideration things like wear and tear, device size, alarms, and the unique status of their child when evaluating whether a device might contribute to some type of adversity and is deserving of an ensuing MedWatch report.

Click here for more on the necessity of medical device adversity reporting.

FDA Seeks Limit of Inorganic Arsenic in Apple Juice

The Food and Drug Administration wants to limit how much inorganic arsenic can be found in apple juice.  If the current proposal is finalized, apple juice made available to consumers wouldn’t be able to post levels higher than 10 parts per billion, the same threshold the Environmental Protection Agency mandates for water.  That’s not to say that persons are going around intentionally poisoning people; inorganic arsenic is a naturally recurring mineral in the environment, and in the past, certain pesticides which contained arsenic may have created residue that seeped in to the soil over time.  The FDA notes that, although samples have shown that inorganic arsenic levels remain low among apple juice products, they want to ensure that consumers are protected from such a potential danger.

Click here for more about this proposal.

Use Caution When Buying Used Children’s Products

Parents looking to save a bit of money may opt to purchase certain products used for their children.  There is nothing wrong with this, but it should be understood that there are some things that ought always to be bought new, and a new report explains why.  Most clothes, for instance, are okay so long as they haven’t been recalled for something like an entrapment hazard (due to drawstrings and the like) or a fire hazard (due to flammable material).  Things like baby monitors and even high chairs may also be acceptable, but again, research should be conducted to verify that current safety requirements are met.  However, most sleep environments should be new.  Crib safety standards change constantly, and you also never know when a vital piece might simply be missing.  Mattresses similarly could be infested with bacteria if used and thus should be purchased new.

For more advice, follow this link.

Florida Parasailing Accident Garners National Attention

If you’re planning on taking a trip to the beach anytime soon, you might let a recent incident act as a warning of the potential dangers of parasailing.  Two teenage girls on vacation in Florida opted to go parasailing under the direction of an outfit known as Aquatic Adventures.  While they were in the air, their line came dislodged from the boat, leaving the girls at the mercy of the winds, which thrust them into a building before they were eventually cast down hard on the ground.  Their injuries were serious, and the event has called into question the safety of some forms of the activity.  Aquatic Adventures was allegedly involved in a previous incident of similar nature that found the parasailers falling into the ocean.

Do your research before going parasailing, and don’t head out on such an excursion unless safety can be completely assured by the operator.  View the video below for more information.

Dispose of Fireworks In The Proper Manner

If you’re still cleaning up fireworks from last week’s festivities, it’s important that you do so in a way that doesn’t compromise your safety or the safety of others.  The State Fire Marshal of Rhode Island explains that all fireworks that never went off as intended need to be drenched in water.  These should be collected along with any spent fireworks and deposited into some kind of container that is itself filled with water.  The debris needs to remain in that position for an hour or so before it’s removed and dumped into the trash to be collected by a relevant agency.  However, consumers would be wise not to recycle any used fireworks, as it could lead to an injury once persons who sift through recyclable materials go about their task.

For more information, click here.

FDA Denies Suvorexant, But Future Approval Still Possible

The Food and Drug Administration has declined to approve a drug called suvorexant from Merck because the dosages proposed by the company could pose a hazard to patients.  When approval was sought, Merck attempted to secure a recommendation of 20 milligrams for adults (15 mg for elderly patients) suffering from insomnia.  If the drug failed to do the trick, they wanted those numbers to be doubled.  However, the FDA has now said that that recommendation should be lowered to 10 mg.  In earlier reports, experts worried that the drug could have an impact on motor function more than 24 hours after administration of the medication.  The ruling seems to suggest that approval of the 10 mg version of the drug is likely.

For more information, click here.

Keeping Barbecues Safe From The Threat Of A Grill Fire

If you’re going to be hosting or attending a barbecue this Independence Day or any other time this summer, you have to make safety a priority, and new tips out of Beaufort County, South Carolina from a representative of the fire department of Lady’s Island explain how to do so.  First, you absolutely need to keep your grill a healthy distance from any structures.  Many people set their grills up on a wooden deck, but if a fire gets out of control, even that could create a hazard.  To ensure safety, you ought to have a fire extinguisher at the ready in order to squelch any flames that get out of hand.  When your’e finished grilling, don’t forget to turn off your propane and stick around for a minute to verify that no leaks have sprung.

Click here for more tips.

Consumer Reports Urges Caution With Off-Brand Cellphone Batteries

The Consumer Product Safety Commission is being urged by Consumer Reports and a New York-based United States Senator to more closely analyze the threat of overheating and fire created when one places an off-brand battery into a cellphone.  Reports have begun to filter in to the CPSC alleging arcing, overheating, and even an incursion of burns among consumers.  Until future regulation is issued, Consumer Reports advises consumers to keep their phones out of both water and extreme heat.  One should refrain from purchasing off-brand batteries until the matter is further settled, and any batteries that are purchased need to be kept far from metal surfaces.

Click here to learn more about the perceived risks.

FDA Exercises Power Over Tobacco Product Makers

The Food and Drug Administration is exercising its power, created by the Family Smoking Prevention and Tobacco Control Act, to regulate tobacco products incoming to the market.  If the seller of an item containing tobacco attempts to market that product, they can file a Substantial Equivalency Marketing Order.  This basically says that the new product has a makeup that is overwhelmingly similar to something that is already for sale.  This doesn’t mean the product is safe or even approved by the FDA, but it does allow it to come to market.  The FDA has for the first time allowed two products to receive this designation, but they’ve denied four others.  The FDA stresses this is only the beginning of their regulatory efforts in this arena and that items which could further compromise public health will not be allowed to be marketed.

For more information, follow this link.

80,300 Capri Track Lights Recalled Due to Dislodging Potential

80,300 sets of Capri track lights are being recalled because of an impact hazard posed.  15 styles are affected by the recall that was issued by the Tupelo, Mississippi-based Genlyte Thomas Group, and these products would have been sold by wholesalers between August 2010 and this past April.  These lights are in danger of becoming dislodged from the track, and thus they could fall down onto persons beneath.  A dozen cracks in the items have been reported, three of which led to the complete dislodging of the lights.  The lights should be taken away from the track and Genlyte should be contacted so that new fixtures can be obtained.

For more about the recall, click here.

FDA Offers Guidance to Prevent Medical Device Hacking

The Food and Drug Administration is offering guidance to medical device manufacturers whose products might be susceptible to infiltration by cyber criminals.  The FDA worries that the onboard computer systems of many devices could be breached, and because such items are typically connected to hospitals, smartphones, and more, the threat could extend beyond even a single device.  To counteract this danger, which the FDA takes pains to state has not to their knowledge prompted a fatality or an injury, hospitals and overseers are being advised to update security software as needed.  Unauthorized usage should be monitored and cracked down on.  Communication between device makers and hospitals is also encouraged so that problems can be reported and corrected immediately.

Follow this link for more about the perceived danger.

Don’t Overpay When Bringing In a Recalled Vehicle for Repairs

A new article explains the process of getting a recall fixed by a dealership.  Prompted by a reader question, the report attempts to lay out how to protect yourself financially when you attempt to obtain recall repairs.  When a recall is issued, you absolutely should not be required to pay for those repairs, even if the initial fix didn’t work.  When a dealer quotes you a price, it could be because they want to find out if an issue with your vehicle stems from something other than a defect.  In such instances, you’ll want to make sure that they’re not going to charge you the quote if it turns out that in fact the recall issue is to blame.

Follow this link for more information.

GOBlock and GOPump Kits Recalled By Symbios Over Health Risk

GOBlock Kits and GOPump Rapid Recovery System Kits are being recalled by Symbios because of a problem that could lead to the improper administration of medication to a patient.  Used to deliver anesthetic as a means to reduce pain in patients, the aforementioned systems may suffer from flow rates that are higher than they should be.  A patient thus receiving anesthetic more quickly than admissible could experience toxicity and ensuing complications, including seizures, irregular heartbeat, and even death.  The recall affects those products with flow control components made before last July.  Letters have reportedly already been sent out warning healthcare professionals about the issue.

For more about the recall, click here.

Fungus Found in Injection Recalled By Main Street Family Pharmacy

Recently, the Newbern, Tennessee-based Main Street Family Pharmacy announced the recall of all sterile compounded items because of fears that they may have been contaminated.  Now, the Food and Drug Administration can confirm that samples of the lots affected have indeed tested positive for a fungus.  The agency will work with the CDC to determine what type of fungus regulators are dealing with.  Persons in Illinois and North Carolina have already reported suffering from skin abscesses in association with an injection from Main Street.  It should be noted it’s the same type of injection that led to an outbreak from last year that claimed the lives of 58 individuals.  The latest recall affects products produced after December 6 of last year.  Each was available in California and a dozen other states.

Click here for more information.

Without a Recall From Chrysler, Consumers Might Explore Other Options

The word has spread that Chrysler is refusing to comply with a recall request issued by the NHTSA, an issue that, while not unprecedented, is certainly unusual.  Thus, owners of the affected Jeep Grand Cherokee and Liberty vehicles might be wondering what they can do to make their vehicles safer in lieu of a recall.  Although a member of the Center for Auto Safety recommends that a steel skid plate be installed above the gas tank, Chrysler itself notes that the plate’s purpose is to protect vehicle components from damage resulting from off-roading.  Because of this, they believe the skid plate would not increase protection during a rear-end collision.  The NHTSA is requesting the recall because of worries that the vehicles might be at risk of a deadly fire if they’re rear-ended.

For more information, follow this link.

Drowning Risk Leads Seattle Company to Recall Scuba Signaling Devices

Scuba diving signaling devices are being recalled by a Seattle company because there’s a chance that a malfunction could lead the user to drown.  The recall was issued by Ideations DiveAlert and concerns those signaling devices that contain a model number of DV2, DP2, or DA2.  On 2,500 of these products, usage could prompt a malfunction that has the potential to limit the air that gets to the diver.  The risk of drowning would then become greater.  Available between July 2009 and this past May across the country, the products should be returned to the diving equipment dealer where they were sold, at which point repairs will be provided at no cost.  The devices were sold around the country.

Follow this link for more about the recall.

NHTSA Looks Into Airbag Issue That Could Prompt 400,000 Vehicle Recall

Since last October, more than 6,800 automobiles have been recalled by General Motors because of an issue involving the front airbags on the driver’s side of the vehicle.  An electrical issue may have led to these airbags not being deployed properly when a crash necessitates inflation.  Now, the National Highway Traffic Safety Administration is attempting to deduce whether or not an additional 400,000 vehicles ought to be recalled as well.  If the NHTSA determines that the problem is sufficient, we could soon see the recall of Chevy Camaro, Cruze, and Sonic vehicles, as well as Buick Veranos, all of the 2012 model year.  Although there have been no reports of injuries, owners of such vehicles should keep an eye on the news to see if they might be affected by the recall.

For more about the investigation, follow this link.

FDA Warns Pregnant Women of Magnesium Sulfate Injection Risks

New labels will be affixed to Magnesium Sulfate Injections warning pregnant women about certain risks posed by the drug.  The Food and Drug Administration wants doctors  and patients alike to understand that therapy that lasts more than five to seven days could lead to complications with the baby.  The injection is typically provided to pregnant women as an off-label way to prevent pregnant women from going into labor pre-term.  The FDA approves the drug for prevention and control of seizures associated with eclampsia or preeclampsia.  The FDA is concerned that more than a week’s treatment can cause a baby to develop low calcium, thin bones, or even fractures. New labels will be put in place to illuminate the threat.

Click here to learn more about the warning.

Advisory Panel Not As Worried About Suvorexant As The FDA

In a move that came as somewhat of a surprise given the Food and Drug Administration’s initial feelings on the matter, an advisory panel has recommended the approval of an anti-insomnia drug from Merck.  The panel convened yesterday let the FDA know that the drug known as suvorexant appears to be both effective and safe for patients.  They explained that doses recommended by Merck seemed appropriate and that insomnia sufferers appear to have been able to get sleep.  What’s interesting is that this runs somewhat counter to the FDA’s own findings.  Reports from earlier in the week suggested that the FDA was concerned about issues with extensive drowsiness after the effects of the drug were supposed to have worn off.  Also troubling the FDA were reports about the onset of suicidal thoughts.

Click here for more about the panel’s thoughts.