Last Updated on June 25, 2024 by The Health Master
Medical Device recall
The safety of medical devices is paramount in healthcare with respect to Medical Device recall.
Recently, the U.S. Food and Drug Administration (USFDA) announced a significant development concerning specific plastic syringes manufactured in China.
This article details the ongoing investigation, Medical Device recall, and important information for healthcare providers and patients.
Medical Device recall: Unapproved Syringes
On June 14, 2024, the USFDA announced that Merit Medical Systems initiated a Medical Device recall of unapproved plastic syringes.
These syringes were supplied by Jiangsu Shenli Medical Production, a Chinese manufacturer.
This action follows the USFDA’s 2023 recommendation to halt the use of certain Chinese-made syringes due to concerning reports of quality issues.
These issues included leaks, breakages, and other potential malfunctions that could compromise patient safety.
USFDA Takes Action Against Multiple Distributors
The USFDA’s efforts extend beyond the recent Merit Medical, Medical Device recall.
In March 2024, the agency issued warning letters to Medline Industries, Sol-Millennium Medical, and Jiangsu Shenli itself.
These letters addressed violations related to the sale and distribution of unauthorized plastic syringes originating from China.
Furthermore, in April 2024, Cardinal Health received a warning letter following an inspection of their Illinois facility.
The inspection revealed that Cardinal Health was marketing and distributing unapproved syringes manufactured by Jiangsu Shenli.
USFDA Continues Evaluation of Syringes Made in China
The USFDA emphasizes its ongoing commitment to evaluating potential problems with syringes manufactured in China.
This evaluation involves reviewing reports, conducting inspections, and collaborating with healthcare providers and manufacturers.
The agency aims to ensure the safety and efficacy of all medical devices used in the United States.
Recommendations for Healthcare Providers and Patients
Healthcare providers and patients should be aware of the following:
- Consult with healthcare providers: If you have concerns about syringes used during a medical procedure, discuss them with your healthcare professional.
- Report any issues: Report any problems encountered with medical devices, including syringes, to the USFDA through the MedWatch program https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
- Stay informed: Monitor the FDA website https://www.fda.gov/medical-devices for updates on this developing situation and other medical device safety alerts.
By working together, healthcare providers, patients, and regulatory agencies can promote patient safety and ensure the quality of medical devices used in the healthcare system.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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