China NMPA Product Recall - Disposable high-pressure injector and accessories - 150ml IIIumena w/ Handifil Linden Luer

The National Medical Products Administration (NMPA) published a recall notice on June 1, 2011, concerning disposable high-pressure injectors and accessories manufactured by Liebel-Flarsheim Company. The recall, initiated voluntarily by the company on October 6, 2010, and formally announced via a recall notice on May 20, 2011, addresses a significant mislabeling issue.

The primary violation involved incorrect packaging and labels for 150ml Illumena w/ Handifil Linden Luer syringes and aspirators (item number 900103, batch number 0253304) being erroneously affixed to different disposable syringes (e.g., item numbers 900618 or 900101). These devices are used in medical imaging procedures like angiography and MRI to inject contrast agents.

The regulatory framework involves the NMPA in China overseeing medical device safety, with the recall being implemented by Covidien, adhering to U.S. Food and Drug Administration regulations. Although the recall affects regions like the United States and Australia, no products from the identified affected batch (0253304) were imported or sold within China.

Required actions include the ongoing voluntary recall of the specific batch by Liebel-Flarsheim, and the NMPA's directive to provincial Food and Drug Administrations to enhance supervision and management of similar products to ensure public safety.