China NMPA Product Recall - puncture biopsy needle

The National Medical Products Administration (NMPA) issued a notice on June 4, 2019, regarding a voluntary Class III recall initiated by GALLINI S.R.L. concerning specific biopsy needles. The manufacturer, represented by its agent Beijing Demate Technology Development Co., Ltd. in China, initiated this recall following customer complaints. The primary issue identified was that biopsy needles from batch number PNN0302-9 were shorter than their specified nominal dimensions. The affected product, a Percutaneous Biopsy Needle (National Medical Device Registration Certificate 20163151260), is designed for extracting tissue samples for cytological or histological biopsies. A total of 800 units of the affected model PCN 22/09 from batch PNN0302-9 were sold in China. Although the dimensional discrepancy was confirmed, GALLINI S.R.L. reported no adverse events related to this issue at the time of recall initiation. Under the NMPA's regulatory oversight, the recall requires specific actions. GALLINI S.R.L. is mandated to inspect warehouses for other products of the same model. Furthermore, customers who received the affected batch are to be notified to return all unsold and unused products. Finally, all recalled products are to be scrapped and destroyed to prevent further distribution. This proactive measure ensures product quality and patient safety within the Chinese market.