FDA Announces Recall of Health Product Due to 'Serious Injuries'
According to the Food and Drug Administration (FDA), "A recall is a method of removing or correcting products that are in violation of laws administered by the FDA." They add that a "recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective."
Now, the FDA has identified a Class I recall of a health product. A Class I recall is the most serious of all recalls, with the FDA describing it as "a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death."
FDA Classifies Most Serious Recall
The FDA has issued a Class I recall of Draeger SafeStar and TwinStar Filters because of a risk of misleading carbon dioxide readings. This is a serious recall, because having the carbon dioxide readings off could result in deadly consequences.
The filters are "bidirectional breathing system filters used during anesthesia and mechanical ventilation." and are designed to filter out contaminants, according to the FDA.
"The use of affected filters may cause serious adverse health consequences, including airway injury, delayed or incorrect treatment, brain injury and death," the FDA states. They add that there were some serious injuries reported because of the slow increase of CO2 curve when using the sampling port of the filter. The good news is that, so far, there have been no reported deaths due to this issue.
"Draeger is recalling these filters due to the risk of misleading capnography (carbon dioxide) readings," the FDA adds, "which could result in health care providers administering unnecessary or harmful treatments based on incorrect waveform interpretations."
So, health care providers and anyone with these devices should stop using them immediately. The FDA adds to contact your Draeger Consumables Representative for information about alternative filters.FDA Announces Recall of Health Product Due to 'Serious Injuries' first appeared on Men's Journal on Aug 12, 2025
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The clearances of the GLORA-4 study by the U.S. FDA and EMA, coinciding with the approval by the China CDE, pave the way for lisaftoclax to potentially become the first Bcl-2 inhibitor approved globally for first-line treatment of higher-risk MDS and the first targeted therapy approved for this indication since the introduction of HMA, which fundamentally reshapes the treatment landscape.' The GLORA-4 trial is being conducted simultaneously in China, the U.S., and Europe. This will significantly accelerate the clinical development of lisaftoclax in MDS and accelerate the drug's path to potential market authorization. Moving forward, we will remain steadfastly committed to our mission of addressing unmet clinical needs in China and around the world, actively advancing our clinical programs for the benefit of more patients.' 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Global epidemiological data of MDS show an exponential increase in incidence with age (22/100,000 in the population aged over 65 years), with a median age of diagnosis of 70 years1. More than 75% of patients with MDS present a complex disease profile that includes at least two comorbidities2. The primary risk of MDS is clonal evolution leading to progression to acute myeloid leukemia (AML), with 40-60% of higher-risk patients (high/very high risk, as classified by IPSS-R) progressing to AML within five years3. These patients have a dismal prognosis and a median survival of less than six months4. As the standard first-line therapy for higher-risk MDS, HMAs offer inadequate responses to treatment, with an overall response rate (ORR) of just 30-40%5, a complete response (CR) rate of 10-17%, and a median duration of response of 9-12 months6, 8. 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Lisaftoclax is already approved in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton's tyrosine kinase (BTK) inhibitors. Previously, the Company released the clinical data of lisaftoclax in combination with AZA in treatment-naïve (TN) MDS during the 2024 American Society of Hematology (ASH) Annual Meeting and the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These data showed an ORR of 75%, much higher than HMAs alone, which demonstrated the clinical benefit of the combination regimen. The combination also showed a favorable safety profile, with a low incidence of severe hematologic toxicities and neutropenia-related infections. In addition, the proportion of patients requiring dose adjustments was low and there were no treatment-related mortalities within 60 days9, 10. Professor Huang commented, 'Despite the significant advancement in the treatment of hematologic malignancies, higher-risk MDS remains a major clinical challenge because of a range of factors. First, the current standard of care treatment with HMAs only offers limited efficacy, with just about one-third of patients achieving a response to treatment. Second, no breakthrough therapies have emerged globally in the two decades since the introduction of HMAs. As a result, there is an unmet clinical need for targeted therapies for higher-risk MDS. The compelling response rate and manageable safety profile observed in earlier studies of lisaftoclax are very encouraging. We hope this global Phase III study has the potential to provide new insights that could benefit how we treat and manage higher-risk MDS.' Dr. Garcia-Manero commented, 'Higher-risk MDS is more prevalent in older populations and thus presents unique clinical challenges. 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For more information, visit Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma's opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma's filings with the SEC, including those set forth in the sections titled 'Risk factors' and 'Special note regarding forward-looking statements and industry data' in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed 'Forward-looking Statements' and 'Risk Factors' in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company's management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma's current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: Hogan Wan, Head of IR and Strategy Ascentage Pharma [email protected] +86 512 85557777 Stephanie Carrington ICR Healthcare [email protected] +1 (646) 277-1282 Media Relations: Jon Yu ICR Healthcare [email protected] +1 (646) 677-1855
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