China NMPA Product Recall - Disposable diaper

Jilin Fulang Medical Technology Co., Ltd. initiated a Level III recall for a batch of its disposable ankle towels (Registration No.: 吉械注准20152640159, Batch Number: 20160405) following a quality supervision and sampling inspection by the National Medical Products Administration (NMPA). The inspection, conducted prior to September 2017, revealed critical product failures related to substandard burst strength and transverse tensile strength in key areas under dry conditions. This non-compliance prompted the company to act in accordance with the NMPA's "Regulations on the Management of Medical Device Recalls."

As part of its corrective action plan, Jilin Fulang Medical Technology Co., Ltd. committed to requiring suppliers to provide factory inspection reports for raw materials, with strict verification against relevant standards. The company also implemented an annual self-inspection program for disposable drapes, submitting samples to authoritative testing institutions for formal inspection. Additionally, it pledged to enhance incoming inspection procedures and bolster raw material quality control. The recall successfully retrieved 250 affected pieces from Changchun City, Jilin Province, by September 12, 2017, which were subsequently isolated for proper handling.