Jan 26, 2022 | Consumer Protection
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 | Shareholder & Investor Protection
Proposal To Enhance Investor Protections And Cybersecurity For Alternative Trading Systems Trading Treasuries And Other Government Securities
The Securities and Exchange Commission announced proposed rules to better protect investors and enhance cybersecurity by bringing more Alternative Trading Systems (“ATS”) that trade Treasuries and other government securities under the regulatory umbrella.
The proposal builds upon a 2020 proposal and public comments received in response to that proposal. It would extend Regulation ATS to include systems that offer the use of non-firm trading interest and provide protocols to bring together buyers and sellers for trading any type of security. These Communication Protocol Systems would be required to either register as exchanges or register as broker-dealers and comply with Regulation ATS.
With ATSs becoming increasingly important to government securities trading, the proposal would expand the investor protections of Regulation ATS to those that trade government securities or repurchase and reverse repurchase agreements on government securities. Additionally, the proposal would expand Regulation Systems Compliance Integrity (“SCI”) to government securities to help increase investor protections and address technological vulnerabilities while improving the SEC’s oversight of the core technology of key entities in the markets for government securities.
Source: SEC.gov
Jan 26, 2022 | Consumer Protection
CFPB Launches Initiative To Save Americans Billions In Junk Fees
The Consumer Financial Protection Bureau (“CFPB”) has launched an initiative to save households billions of dollars a year by reducing exploitative junk fees charged by banks and financial companies. The CFPB’s request is a chance for the public to share input that will help shape the agency’s rulemaking and guidance agenda, as well as its enforcement priorities in the coming months and years.
According to the CFPB, companies across the U.S. economy are increasingly charging inflated and back-end fees to households and families. This new “fee economy” distorts the U.S. free market system by concealing the true price of products from the competitive process. For example, hotels and concert venues advertise rates, only to add “resort fees” and “service fees” after the fact. And fees purportedly charged to cover individual expenses, like paperwork processing, can often greatly exceed the actual cost of that service.
The CFPB’s research has found several areas where back-end fees might obscure the true cost of a product and undermine a competitive market:
- In 2019, the major credit card companies charged over $14 billion each year in punitive late fees.
- In 2019, bank revenue from overdraft and non-sufficient funds (“NSF”) fees surpassed $15 billion .
The CFPB will strive to strengthen competition in consumer finance by using its authorities to reduce these kinds of junk fees. To craft rules, issue industry guidance, and focus supervision and enforcement resources to achieve this goal, the CFPB is seeking input from the public.
The CFPB is interested in hearing about people’s experiences with fees associated with their bank, credit union, prepaid or credit card account, mortgage, loan, or payment transfers, including:
- Fees for things people believed were covered by the baseline price of a product or service
- Unexpected fees for a product or service
- Fees that seemed too high for the purported service
- Fees where it was unclear why they were charged
The CFPB is also interested in hearing from small business owners, non-profit organizations, legal aid attorneys, academics and researchers, state and local government officials, and financial institutions, including small banks and credit unions.
Source: Consumerfinance.gov
If you believe you have been harmed due to fees you believed were covered by the baseline price of a product or service; unexpected fees for a product or service; fees that seemed too high for the purported service; or fees where it was unclear why they were charged, please contact Kehoe Law Firm, P.C. by completing the form above on the right or via [email protected] for a free, no-obligation evaluation of potential legal claims.
Jan 26, 2022 | Shareholder Investigations
Kehoe Law Firm, P.C. is investigating potential violations of federal securities laws by Gatos Silver, Inc. (“Gatos Silver” or the “Company”) (NYSE: GATO).
On January 25, 2022, Gatos Silver stated that “[d]uring the Company’s resource and reserve update process for the Los Gatos Joint Venture (‘LGJV’), which included a detailed reconciliation of recent production performance, the Company concluded that there were errors in the technical report entitled ‘Los Gatos Project, Chihuahua, Mexico’ with an effective date of July 1, 2020 (the ‘2020 Technical Report’), as well as indications that there is an overestimation in the existing resource model.”
Gatos Silver also stated that “[o]n a preliminary basis, the Company estimates a potential reduction of the metal content of Cerro Los Gatos’ (‘CLG’) mineral reserve ranging from 30% to 50% of the metal content remaining after depletion. Since the 2020 Technical Report, depletion is 1.3 million tonnes grading 284 g/t silver, 3.9% zinc, 2.3% lead and 0.3 g/t gold that has been processed from July 1, 2020 to December 31, 2021. At this time, the Company cannot accurately quantify the exact magnitude of the reduction, and the mineral resource and reserve estimates in the 2020 Technical Report should not be relied upon.”
On this news, the stock price of Gatos Silver was down more than 66% during intraday trading on January 26, 2022.
Jan 26, 2022 | Car Problems Car Complaints
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.
