China NMPA Product Recall - Disposable sterile urinary catheterization kit

Qing'an Spring Medical Device Technology Co., Ltd. initiated a voluntary Class III recall for its "Disposable Sterile Urinary Catheter Kits" after a specific production batch (190301) failed testing for Ethylene Oxide (EO) residue. This critical issue was identified during a 2019 national medical device spot check conducted under the oversight of the National Medical Products Administration (NMPA). The recall, publicly announced on September 26, 2019, was undertaken by the company to mitigate potential risks associated with elevated EO levels, which are used for sterilization but must be within safe limits post-processing. While the document doesn't specify an exact inspection date, the problem was discovered as part of a routine regulatory review within 2019. The NMPA framework mandates that companies address product deficiencies promptly, and Qing'an Spring Medical Device Technology Co., Ltd. responded by recalling the affected units. Further details regarding the specific models, specifications, and batches involved are documented in the "Medical Device Voluntary Recall Event Report Form." This action highlights the importance of rigorous quality control and adherence to safety standards in medical device manufacturing.