China NMPA Product Recall - Disposable puncture care kit

Haolang Technology (Foshan) Co., Ltd. initiated a voluntary Class III recall of its Disposable Puncture Care Kits in August 2019, under the regulatory oversight of China's National Medical Products Administration (NMPA). The recall primarily affects product batch number 1904018, manufactured in April 2019. The main issue identified was an inconsistency between the actual product configuration and its registered specifications (model CH-09). Specifically, essential components such as a scalpel, butterfly clamp, and forceps were missing from the kits. While the company noted that these kits are often used with CVC catheter kits that already contain these instruments and no adverse events have been reported, the deviation from registered design necessitates corrective action. As required actions, Haolang Technology instructed distributors to issue recall notices to their customers and retrieve all affected products. These returned kits are to be sent back to Haolang Technology (Foshan) Co., Ltd. for proper disposal, ensuring compliance with medical device standards.