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In light of recent developments regarding the FDA’s investigation of syringes manufactured in China,
we want to take this opportunity to reaffirm our disposable syringe with unrivaled quality and reliability.
On March 18, 2024, the FDA issued warning letters to multiple manufacturers in China, citing various
violations. Furthermore, the FDA’s safety communication highlighted that issues with syringes made in
China are more widespread than previously known, prompting a recommendation for immediate transition away from such products.
The agency first made its worries public late last November, after it collected reports of leaks, breakages
and other problems. The probe’s scope was limited to imports of standard plastic syringes—glass or
prefilled syringes, as well as those designed for oral or topical uses, have not been affected.
On 16th May,2024,FDA suggested that Immediately transition away from using plastic syringes
manufactured by several China-based manufacturers, unless use of these syringes is absolutely
necessary until you can complete the transition to syringes that are not manufactured in China,and
our company is not in the list.For all other plastic syringes made in China,the FDA’s evaluation
remains ongoing.
About the problem of potiential syringe failures such as leaks, breakage, and other problems after
manufacturers made changes to the syringe dimensions,we have solved them.Our syringe are produce
according to ISO standard.Every production process are checked by several quality inspectors. Also,
there are several inspection equipment ineach machine.Many quality problems are avoided.
Quick Response within 24 hours!
Tel: (+)86-519-88168398
WhatsApp: +86-13961432323
Email: sale01@lelun.com
HengShanQiao Town, out of East Gate, Changzhou ,Jiangsu, China
Changzhou Medical Appliances General Factory Co., Ltd. was built in 1988, it is a modern factory specialized in producing the disposable medical appliances in China. The factory is only 1km to Hengshan entrance of Huning high-speed road and is about 20 miles to Changzhou airport. So the traffic is convenience.
The area of the factory is 40000㎡, the area of purifying workshop is 7000m, and fixed assets are about 5,000,000USD. Our main products are Disposable infusion sets, Disposable blood transfusion sets, Disposable Sterile syringe sets, latex glove, disposable infusion set, simple oxygen mask, nebulizer mask, urine cup, hernia mesh, urine bag etc. Now we can manufacture more than 200,000,000 sets per year.