China NMPA Product Recall - oropharyngeal airway
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Teleflex Medical initiated a global recall of certain models of its oropharyngeal airways, as reported by the National Medical Products Administration (NMPA) on May 2, 2012, with the recall event specifically reported on April 23, 2022. The recall stems from complaints regarding the airway handle cracking during use. This issue presents a significant patient safety risk, as a fractured handle may necessitate additional medical intervention for its removal from a patient's airway or esophagus, potentially causing further complications. Although Teleflex Medical states that the affected products were not registered or marketed in the Chinese market, the NMPA has requested provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management of such medical devices. As part of the corrective actions, the company has instructed all distributors and customers to immediately cease using and isolate the recalled products. They are also required to inspect their inventory for affected items and inform all customers who received the recalled products about this notice. This comprehensive recall aims to mitigate potential patient harm and ensure product safety globally, even as the Chinese market remains unaffected by the direct product distribution.
- Company
- Teleflex Medical
ID · f5db411e-ef0e-473c-9aed-208a03b98302