Jan 26, 2022 | Archive
Philips Respironics Recalls Certain Trilogy EVO Ventilators For Potential Health Risks From PE-PUR Foam
Recalled Products & Model Numbers
- Manufacturing Dates: April 15, 2021 to May 24, 2021
- Distribution Dates: April 15, 2021 to May 24, 2021
- Devices Recalled In The U.S.: 215 Trilogy Evo ventilators; 51 Trilogy Evo repair kits
- Date Initiated By Firm: December 21, 2021
NOTE: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. Certain other Trilogy models are NOT AFFECTED by this issue and are NOT SUBJECT TO THE RECALL: Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal.
Reason For The Recall
Philips Respironics has recalled certain Trilogy Evo ventilators with specific serial numbers due to potential health risks. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material, in the muffler assembly of the affected Trilogy Evo ventilators. The issue was identified during lab testing of the Trilogy Evo ventilator. The Trilogy Evo ventilators with non-conforming foam were distributed to customers in the United States and Korea. There have been no reported injuries or death to date.
The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
For more information, please see the Potential Health Risks from Sound Abatement Foam section of the Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.
Who May Be Affected
- People using these devices and their caregivers
- Health care providers and facilities
- Durable Medical Equipment (“DME”) suppliers
What To Do
Philips Respironics sent an Urgent Medical Device Recall notification to Trilogy Evo ventilator customers on December 21, 2021, and the company sent an updated version to clarify information on cleaning and filters on January 13, 2022.
The notification requested customers take the following actions:
- Create awareness of this safety information by forwarding to your organization’s personnel.
- Identify all of the impacted devices purchased by your organization.
- Do not stop or change patient therapy unless the patient has consulted their health care provider or unless a replacement Trilogy Evo ventilator has been provided.
- Instruct patients and/or caregivers to closely monitor the bacteria filter for foam debris. Using an inline bacterial filter may help to filter out particles of foam. Additionally, after placement of an inline filter, instruct patients and/or caregivers to be aware of potential changes in breathing circuit resistance and monitor as ventilator performance may change due to increase in resistance of air flow through the device after filter placement. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.
- Inspect and clean the patient circuit and accessories per the instructions included with the notification.
- A replacement Trilogy Evo ventilator will be provided by Philips. Once the patient has been transitioned, return the affected Trilogy Evo ventilator to Philips. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. The packing instructions are in Appendix A of the notification.
For the repair kit for Trilogy Evo muffler assembly, the December 21, 2021 notification letter requested customers take the following actions:
- Segregate inventory of Repair Kit – Trilogy Evo Muffler Assembly Part Number 1135257, and quarantine any lot between 210414 and 210524.
- Do not use any quarantined material and contact Philips for return instructions. You will be shipped replacements.
- Determine if any Trilogy Evo devices have been repaired using Trilogy Evo Muffler Assembly Part Number 1135357 starting 14 April 2021 or later
- If the lot number used in repair is between 210414 and 210524. Contact Philips for next steps. Philips will replace the device these parts were installed into.
- If the lot number used in a repair is unknown, assume it is affected and contact Philips for next steps. Philips will replace the device these parts were installed into.
- If lot number is known and is not an affected lot, no further action is required.
For more information, please see the Recommendations section of the Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.
Contact Information, Full List Of Affected Devices & Additional Resources
Customers in the U.S. with questions about this recall should contact Philips Respironics at (800) 722-9377 or email [email protected].
A complete list of affected devices is available in the Medical Device Recalls database.
- Medical Device Recall Database Entries:
Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
Source: U.S. Food & Drug Administration (Philips Respironics Recalls Certain Trilogy EVO Ventilators For Potential Health Risks From PE-PUR Foam).
If you have been the victim of a defective or misleading consumer product and/or product recall, please complete the form on the right or e-mail [email protected] for a free, no-obligation evaluation of potential legal claims.
Jan 26, 2022 | Archive
Nissan Rogue (2014-2016)
Electrical connector under dash may corrode. Nissan North America, Inc. is recalling certain 2014-2016 Rogue vehicles. The electrical connector for the under dash harness may corrode due to water and salt intrusion from the driver’s side foot well. Corrosion in the electrical connector can result in power window/seat failure, all-wheel-drive warning light illumination, battery drainage, and electrical connector damage that increases the risk of a fire. For additional information about this safety recall, which potentially affects 688,946 vehicles, please click NHTSA Campaign Number: 22V024000.
How Do You Know If Your Vehicle Has Been Recalled?
Your vehicle MAY be involved in a safety recall which MAY create a safety risk for you or your passengers. If not repaired, a potential safety defect could lead to injury or even death. Safety defects must be repaired by a dealer at no cost to you. To find out if your vehicle is included in the recall, please use the NHTSA’s VIN Look-up Tool.
What Is A Vehicle Recall?
When a manufacturer or the NHTSA determines that a vehicle creates an unreasonable risk to safety or fails to meet minimum safety standards, the manufacturer is required to fix that vehicle at no cost to the owner. The fix, or repair, can be accomplished by repairing, replacing, offering a refund (for equipment) or, in rare cases, repurchasing the car/vehicle.
What Should I Do If My Vehicle Is Included In This Recall?
If your vehicle is included in a specific recall, it is very important that you get it fixed as soon as possible given the potential danger to you and your passengers if it is not addressed. You should receive a separate letter in the mail from the vehicle manufacturer, notifying you of the recall and explaining when the remedy will be available, whom to contact to repair your vehicle, and to remind you that the repair will be done at no charge to you. If you believe your vehicle is included in the recall, but you do not receive a letter in the mail from the vehicle manufacturer, please call NHTSA’s Vehicle Safety Hotline at 1-888-327-4236, or contact your vehicle manufacturer or dealership.
For additional information about vehicle recalls, please click Vehicle Recall FAQs.
Source: U.S. Department of Transportation, National Highway Traffic Safety Administration
VEHICLE OWNERS AND LESSEES AFFECTED BY AUTOMOTIVE DEFECTS OR SAFETY RECALLS ARE ENCOURAGED TO COMPLETE THE FORM ABOVE ON THE RIGHT OR CONTACT KEHOE LAW FIRM, P.C., [email protected], FOR A FREE, NO-OBLIGATION EVALUATION OF POTENTIAL LEGAL CLAIMS.
Jan 24, 2022 | Archive
Conditional Validity Of Product Warranties For Gillette, Venus, Braun & Oral-B Products At Issue In Class Action Lawsuit
On January 21, 2022, a class action complaint was filed against The Procter & Gamble Company and The Gillette Company LLC (“P&G,” “Gillette,” or “Defendants”) for the manufacture, marketing, and sale of consumer products sold under brand names that include Gillette, Venus, Braun, and Oral-B.
According to the class action complaint, the lawsuit was brought against the Defendants for the marketing, manufacture and/or sale of consumer products, the warranties of which include statements that condition the continued validity of the warranty on the use of only an authorized repair service and/or authorized replacement parts (i.e., a “tying arrangement”).
Tying arrangements that condition a consumer product’s warranty on the use of a specific repair service in this manner violate state and federal law, according to the complaint. The Defendants, allegedly, exacerbate these violations by stating on the outside of the product packaging that the consumer products include a one-year limited warranty, but the unlawful repair restriction is not revealed to the consumer until after the point of sale. Moreover, the Plaintiffs and other class members would not have purchased a particular product, or would have paid much less, if the unlawful repair restriction was known.
The complaint alleges that the Defendants condition warranty coverage on unlawful repair restrictions, and in numerous instances, the Defendants, via their warranty statements for various appliances, condition warranty coverage on the use of the Defendants’ repair services to perform maintenance and repair work, rather than allowing consumers to repair the product themselves or take it to a third-party repair service.
By conditioning their warranty in this manner, the Defendants, according to the complaint, have violated the tying prohibition in the Magnuson-Moss Warranty Act, which prohibits companies from conditioning their warranties on the consumer’s use of any article or service (other than an article or service provided without charge under the terms of the warranty) identified by brand, trade, or corporate name.
If you purchased Gillette, Venus, Braun, and Oral-B products in the United States with a warranty provision that prohibits self-repair and/or the use of unauthorized parts, you are encouraged to contact Kehoe Law Firm, P.C. by completing the form above on the right or via [email protected] for a free evaluation of potential legal claims.
Jan 21, 2022 | Archive
On January 21, 2022, the Securities and Exchange Commission (“SEC”) announced three awards totaling more than $40 million to four whistleblowers who provided information and assistance in three separate covered actions.
In the first order, the SEC issued an award of approximately $37 million to two joint whistleblowers who provided key evidence that contributed to the success of the covered action. The whistleblowers also provided ongoing assistance and helped SEC staff identify additional information that advanced the investigation.
In the second order, the SEC issued approximately $1.8 million to a whistleblower who provided important, new information that prompted SEC staff to open an investigation into the misconduct. The whistleblower continued to assist SEC staff by providing interviews and additional documents.
In the third order, the SEC awarded approximately $1.5 million to a whistleblower who provided new information that shaped the SEC staff’s investigative strategy and significantly contributed to the success of the covered action. The whistleblower also provided substantial and ongoing assistance by helping SEC staff identify issues.
The SEC has awarded approximately $1.2 billion to 245 individuals since issuing its first award in 2012.
All payments are made out of an investor protection fund established by Congress that is financed entirely through monetary sanctions paid to the SEC by securities law violators. No money has been taken or withheld from harmed investors to pay whistleblower awards.
As set forth in the Dodd-Frank Act, the SEC protects the confidentiality of whistleblowers and does not disclose any information that could reveal a whistleblower’s identity.
Source: SEC.gov
Questions Or Concerns About Voluntarily Providing Information To The SEC And Whistleblower Award Eligibility?
If you have questions or concerns about voluntarily providing information to the SEC regarding violations of the federal securities laws, including questions about whistleblower award eligibility, or the form and manner in which the information is required to be provided to the SEC, please contact Kehoe Law Firm, P.C. by completing the form above on the right, sending an e-mail to [email protected] or by contacting either Michael Yarnoff, Esq., [email protected], (215) 792-6676, Ext. 804, or John Kehoe, Esq., [email protected], (215) 792-6676, Ext. 801.
Jan 19, 2022 | Archive
On January 14, 2022, a class action lawsuit was filed in United States District Court, Central District of California, against Ford Motor Company, Inc. (“Ford”) and other defendants, as of yet unknown, stemming from Ford’s alleged failure to accurately and comprehensively identify the vehicle parts that should properly be classified as “high-cost emissions warranty parts” under California’s emission warranty requirements and covered under the emissions warranty for 7-years and 70,000 miles.
According to the lawsuit, Ford, to minimize its warranty exposure, unilaterally limited the parts that should be covered under the emissions warranty for 7-years and 70,000 miles, including the parts specifically identified by the Plaintiff. Ford, according to the complaint, by not comprehensively identifying the parts that should be included as “high-cost” warranty parts, is able to limit the warranty coverage for those parts, thus saving money.
The lawsuit is seeking reimbursement for, among other things, all out of pocket costs paid for repairs that should have been covered under the 7-years and 70,000-mile emissions warranty and an injunction to compel Ford to properly identify parts as high-priced warranty parts.
The Class Vehicles are defined in the class action complaint as all Ford vehicles with the following proposed Classes:
Cylinder Head & Cylinder Wall Classes – All persons in California who have been owners or lessees of Class Vehicles and who have paid for repairs and parts pertaining to defective cylinder heads and cylinder walls that should have been covered under Ford’s “high-priced warranted parts” 7-year 70,000-mile California emissions warranty.
“High-Cost Class” – All persons in California who have been owners or lessees of Class Vehicles and who have paid for repairs and parts that should have been covered under Ford’s “high-priced warranted parts” 7-year 70,000-mile California emissions warranty.
VEHICLE OWNERS AND LESSEES AFFECTED BY AUTOMOTIVE DEFECTS OR SAFETY RECALLS ARE ENCOURAGED TO COMPLETE THE FORM ABOVE ON THE RIGHT OR CONTACT KEHOE LAW FIRM, P.C., [email protected], FOR A FREE, NO-OBLIGATION EVALUATION OF POTENTIAL LEGAL CLAIMS.
Jan 19, 2022 | Archive
Ford E-350 (2021-2022) / Ford E-450 (2021-2022)
Power steering pressure line may detach and leak. A sudden loss of power steering fluid can result in a loss of power steering and power brake assist, increasing the risk of a crash. For more information about this recall, which potentially affects 44,219 Ford vehicles, please click NHTSA Campaign Number: 22V089000.
Ford Explorer (2022) / Lincoln Aviator (2022)
Fuel filler tube may detach. A detached fuel filler tube can result in a fuel leak, increasing the risk of a fire. For more information about this recall, which potentially affects 18,078 Ford vehicles, please click NHTSA Campaign Number: 22V088000.
Ford F-250 SD (2017-2022) / Ford F-350 SD (2017-2022)
Damaged drive shaft may fracture. A fractured driveshaft can cause a loss of drive power, or a loss of vehicle control if the driveshaft contacts the ground. Additionally, unintended movement could occur while parked if the parking brake is not engaged. Any of these scenarios can increase the risk of a crash. Ford Motor Company is recalling certain 2017-2022 F-250 and F-350 Super Duty vehicles equipped with gasoline engines and aluminum driveshafts. Underbody heat and noise insulators may loosen and contact the aluminum driveshaft, which could damage the driveshaft and cause it to fracture. For more information about this recall, which potentially affects 247,445 Ford vehicles, please click NHTSA Campaign Number: 22V087000.
Ford Mustang (2015-2017)
Blank or distorted rearview camera image. A rearview camera that displays a blank or distorted image can reduce the driver’s rear view, increasing the risk of a crash. Ford Motor Company is recalling certain 2015-2017 Mustang vehicles. The rearview camera wiring may be loose or damaged, which can result in a blank or distorted image. For more information about this recall, which potentially affects 330,784 Ford Mustangs, please click NHTSA Campaign Number: 22V082000.
2021 Ford Super Duty F-250 / F-350 SD / F-450 SD / F-550 SD / F-600 SD / F-650 / F750
Secondary fuel filter may leak. A fuel leak in the presence of an ignition source can increase the risk of a fire or injury. Ford is recalling certain 2021 Super Duty F-250, F-350, F-450, F-550, F-600, and Medium Duty F-650 and F-750 vehicles equipped with 6.7L diesel engines, as a small void may be present in the top-center of the vehicle’s underhood secondary fuel filter cap, which may progress to a pinhole over time, allowing fuel to leak from the top of the secondary fuel filter. For more information about this recall, which potentially affects 19,697 Ford vehicles, please click NHTSA Campaign Number: 22V013000.
Ford Fusion (2014-2015) / Ford Mustang (2015) / Lincoln MKZ (2014-2015)
Brake light malfunction and possible rollaway risk. A separated brake pedal bumper can cause the brake lights to illuminate continuously, causing confusion to other drivers and increasing the risk of a crash. On automatic transmission vehicles, a missing brake pedal bumper can allow the driver to shift the vehicle out of the “PARK” position without depressing the brake, allowing the vehicle to roll away, increasing risk of injury. Ford Motor Company is recalling certain 2014-2015 Fusion, Lincoln MKZ, and 2015 Mustang vehicles originally sold or ever registered, in Texas, Louisiana, Mississippi, Alabama, Florida, Georgia, South Carolina, North Carolina, Virginia and Hawaii. Exposure to certain environmental conditions, such as high temperatures, high humidity, and salt air can cause the brake pedal bumper to corrode and separate from the brake pedal. For additional information about this recall, which potentially affects 199,085 Ford vehicles, please click NHTSA Campaign Number: 22V011000.
How Do You Know If Your Vehicle Has Been Recalled?
Your vehicle MAY be involved in a safety recall which MAY create a safety risk for you or your passengers. If not repaired, a potential safety defect could lead to injury or even death. Safety defects must be repaired by a dealer at no cost to you. To find out if your vehicle is included in the recall, please use the NHTSA’s VIN Look-up Tool.
What Is A Vehicle Recall?
When a manufacturer or the NHTSA determines that a vehicle creates an unreasonable risk to safety or fails to meet minimum safety standards, the manufacturer is required to fix that vehicle at no cost to the owner. The fix, or repair, can be accomplished by repairing, replacing, offering a refund (for equipment) or, in rare cases, repurchasing the car/vehicle.
What Should I Do If My Vehicle Is Included In This Recall?
If your vehicle is included in a specific recall, it is very important that you get it fixed as soon as possible given the potential danger to you and your passengers if it is not addressed. You should receive a separate letter in the mail from the vehicle manufacturer, notifying you of the recall and explaining when the remedy will be available, whom to contact to repair your vehicle, and to remind you that the repair will be done at no charge to you. If you believe your vehicle is included in the recall, but you do not receive a letter in the mail from the vehicle manufacturer, please call NHTSA’s Vehicle Safety Hotline at 1-888-327-4236, or contact your vehicle manufacturer or dealership.
For additional information about vehicle recalls, please click Vehicle Recall FAQs.
Source: U.S. Department of Transportation, National Highway Traffic Safety Administration
VEHICLE OWNERS AND LESSEES AFFECTED BY AUTOMOTIVE DEFECTS OR SAFETY RECALLS ARE ENCOURAGED TO COMPLETE THE FORM ABOVE ON THE RIGHT OR CONTACT KEHOE LAW FIRM, P.C., [email protected], FOR A FREE, NO-OBLIGATION EVALUATION OF POTENTIAL LEGAL CLAIMS.
