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The company has a long-standing reputation in the Chinese medical device industry, producing over 55 varieties of disposable medical devices primarily for export. US FDA has issued multiple warning letters and import bans in 2024 due to quality system violations, unauthorized product modifications, and patient safety risks for plastic syringes. Recalls have affected millions of units distributed via US partners (Medline, Merit, Cardinal Health). FDA clearance for original 5mL luer lock piston syringe (K103830); most other syringe modifications not cleared/approved for US market.
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