China NMPA Product Recall - Indwelling catheter

The National Medical Products Administration (NMPA) announced a recall initiated by Gambro Kathetertechnik Hechingen for its indwelling catheters, distributed in China by Gambro Kidney Care Products (Shanghai) Co., Ltd. The recall, published on July 30, 2013, stemmed from an internal inspection by Gambro revealing that some GamCath short-term catheters might have incompletely sealed sterile bags. This manufacturing defect posed a potential risk of patient infection if the product were used, although no adverse events were reported prior to the recall.

Under the NMPA's regulatory oversight, Gambro implemented specific corrective actions. On July 11, 2013, the company verbally notified its sole Chinese distributor to immediately seal the 20 affected product sets, none of which had reached hospitals. A formal written notification was scheduled to be sent by July 19, 2013, requiring customer signatures. The required actions involve returning the sealed products for destruction or replacement, with provincial food and drug administrations instructed to enhance supervision of these products to ensure public safety.