China NMPA Product Recall - Disposable sterile urinary catheter

Dalian Kuliaite Medical Products Co., Ltd. has initiated a voluntary Class III recall for its disposable sterile urinary catheters. This action, publicly reported on November 13, 2019, by the Liaoning Provincial Drug Administration under the National Medical Products Administration (NMPA) framework, addresses a critical quality concern. The primary issue identified pertains to the three-lumen 22Fr 30ml disposable sterile urinary catheters, specifically regarding the reliability of the balloon component. Investigations confirmed that the balloon's performance failed to meet the company's own registered product standards, indicating a deviation from approved specifications.

As a result, Dalian Kuliaite Medical Products Co., Ltd. is voluntarily recalling 34 units of these affected catheters (Registration Certificate No.: Liaoning Food and Drug Administration Medical Device (Approval) No. 20142660160). No specific inspection dates were provided in the document leading to a forced recall; rather, this was a company-initiated action. The Class III recall level suggests that the use of or exposure to the non-compliant product is not likely to cause adverse health consequences. Comprehensive details regarding the specific models, specifications, and batches involved are referenced in an accompanying "Medical Device Recall Event Report Form," which guides healthcare providers and distributors in identifying and managing affected products. This voluntary measure underscores the company's commitment to product quality and adherence to regulatory standards established by the NMPA and its provincial branches.