China NMPA Product Recall - Disposable breathing tubing

Fisher & Paykel Healthcare (Guangzhou) Co., Ltd. has initiated a voluntary Class II recall of its disposable breathing tubes (National Medical Device Registration Certificate No.: 20152663810). The recall, reported to the National Medical Products Administration (NMPA) on October 16, 2017, and published on October 23, 2017, addresses a critical product issue. There were no specific inspection dates noted, as this was a company-initiated voluntary recall.

The primary concern is an increasing probability of rupture at the nozzle of certain breathing extension tubes. This defect poses a significant risk of patient hypoxia due to tube leakage if the device is not continuously monitored during use. The affected models include RT021, with specific batch numbers 0000101843 and 0000101851, impacting 220 units sold in China.

In response, Fisher & Paykel Healthcare has outlined several required actions under the NMPA regulatory framework. Distributors of the affected product batches are instructed to immediately cease sales. The company is actively contacting customers who have purchased these products to arrange for their return, with all returned items slated for destruction in compliance with regulations. Furthermore, for products currently in use, the company is proactively engaging with customers to inquire about usage and collect any suspected adverse reactions related to the defective tubes. This comprehensive recall aims to mitigate potential patient safety risks associated with the faulty medical devices.