China NMPA Product Recall - Disposable varicose vein injection needles
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Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class II recall of its disposable varicose vein injection needles on June 14, 2019. This action was taken due to a reported defect involving needle lumen blockage in some product batches. The recall was announced by the National Medical Products Administration (NMPA) and is associated with the Shanghai Food and Drug Administration Medical Device Registration Certificate. The company, operating under the regulatory oversight of the NMPA, identified the critical product flaw which necessitated the recall to ensure patient safety and product efficacy. Further specific details regarding the affected models, specifications, and batch numbers were made available through a Medical Device Recall Event Report Form. This voluntary recall underscores the company's commitment to addressing product quality issues under the established regulatory framework.
ID · 61f7a94c-706d-4d47-a995-4658868a4bbb