Plastic syringes manufactured by Jiangsu Shenli Medical Production have prompted Merit Medical Systems to initiate a recall of products containing these plastic syringes, according to an announcement by the Food and Drug Administration (FDA) on Friday. This action comes in the wake of broader FDA scrutiny of plastic syringes produced in China, focusing on potential quality issues such as leakage, breakage, and overall reliability concerns.
The recall affects various kits that include unauthorized plastic syringes from Jiangsu Shenli. Earlier this year, the FDA issued an import alert and a warning letter against the Chinese manufacturer after discovering that the plastic syringes provided differed from the company’s authorized devices. Merit Medical informed its customers last week about the recall, urging them to cease using the affected plastic syringes immediately.
The FDA’s investigation into Chinese-manufactured plastic syringes led them to identify significant issues with products from Jiangsu Shenli. The agency accused the company of marketing 29 different sizes and configurations of piston syringes without the necessary clearance or approval. This scrutiny resulted in the identification of potential risks, including the plastic syringes’ propensity to leak, break, or suffer other quality problems.
Medline and Merit Medical Recall Jiangsu Shenli Plastic Syringes Amid FDA Safety Warnings
Medline Industries, another company implicated in the distribution of Jiangsu Shenli plastic syringes, received a warning letter from the FDA and subsequently recalled its devices in May and June. This broader industry issue underscores the FDA’s commitment to ensuring the safety and efficacy of medical devices, particularly those used in critical healthcare settings.
Merit Medical’s response to the situation included sending an urgent medical device recall notice to its customers, detailing the inclusion of Jiangsu Shenli syringes in multiple products. While customers are advised to discontinue the use of these plastic syringes immediately, they may continue to use other components included in the kits. To manage potential product shortages during the transition away from Jiangsu Shenli syringes, Merit Medical may still ship kits containing the affected devices, albeit with a recall label applied to the plastic syringes.
According to the FDA’s Class 2 recall notice, approximately 110,000 devices are affected. These include disposable luer lock syringes sold under the Medigrative brand, with Jiangsu Shenli listed as the recalling firm. The company has instructed customers to dispose of the recalled syringes through their established procedures or by coordinating with a local third-party service. Customers are also required to report the destruction method and associated costs to Jiangsu Shenli before final implementation.
Merit Medical and Medline Recall Highlights FDA’s Focus on Medical Device Safety
Merit Medical’s recall comes just days after the FDA announced additional recalls by Medline Industries, which began recalling luer lock disposable syringes shortly after an initial action that impacted 2.3 million devices. This series of recalls highlights the FDA’s proactive measures to address and mitigate risks associated with substandard medical devices.
The recall initiated by Merit Medical underscores the critical importance of quality assurance in medical device manufacturing and distribution. The FDA’s rigorous oversight ensures that devices used in healthcare settings meet stringent safety and performance standards, thereby protecting patients and healthcare providers from potential harm. As the medical device industry continues to evolve, manufacturers must prioritize stringent quality control measures and compliance with regulatory standards. The recent recalls serve as a reminder of the potential consequences of lapses in these areas and the importance of maintaining transparency and accountability throughout the supply chain.
In conclusion, Merit Medical’s recall of plastic syringes from Jiangsu Shenli, prompted by FDA scrutiny, highlights ongoing challenges in ensuring the quality and safety of medical devices. The collaborative efforts of regulatory bodies, manufacturers, and distributors are essential in addressing these issues and safeguarding public health. As the industry adapts to these challenges, the emphasis on quality assurance and regulatory compliance will remain paramount in delivering safe and effective medical devices to the market.
Resource: Food and Drug Administration, June 14, 2024
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