China NMPA Product Recall - Medical rubber examination gloves
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The National Medical Products Administration (NMPA) announced a voluntary Class III recall by Chongqing Hongguan Medical Equipment Co., Ltd., published on December 24, 2019. This action, initiated following a report dated December 16, 2019, addresses issues with their Medical Rubber Examination Gloves (registration number 渝械备20140025号). The core violation identified by the Chongqing Medical Device Quality Inspection Center was that a specific batch of gloves (batch number 20180716, 3000 pairs of small size) failed to meet the required technical specifications for tensile strength and elongation at break before aging. Under NMPA’s regulatory framework, Chongqing Hongguan Medical Equipment Co., Ltd. undertook several corrective actions. The company's quality department initiated the recall, and the sales department promptly notified customers to halt distribution. All recalled products were then collected, verified, and segregated. The final step mandates the destruction of these non-conforming products under the direct supervision of regulatory authorities to ensure they are removed from circulation.
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