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

Source: https://www.globalkeysolutions.net/records/china_product_recall/liebel-flarsheim-company/75ca0b8c-cb2b-405e-b950-ffcf96f87a6c/
Source feed: China

> China NMPA product recall for Disposable high-pressure injector and accessories - 150ml IIIumena w/ Handifil Linden Luer by Liebel-Flarsheim Company published June 01, 2011. Recall level: . The National Medical Products Administration (NMPA) published a recall notice on June 1, 2011, conce

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Liebel-Flarsheim recalls disposable high-pressure injectors and accessories.
- Company Name: Liebel-Flarsheim Company
- Publication Date: 2011-06-01
- Product Name: Disposable high-pressure injector and accessories - 150ml IIIumena w/ Handifil Linden Luer
- Recall Reason: The packaging and label of the 150 ml IIIumena w/ Handifil Linden Luer 150ml syringe and aspirator, item number 900103 and lot number 0253304, are affixed to the 150 ml Syringe 150 ml Disposable syringe and aspirator, item number 900618.
- Discovering Company: Singapore Tyco Medical Devices Co., Ltd. Beijing Office
- Manufacturing Company: Liebel-Flarsheim Company
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/liebel-flarsheim-company/03789a8a-27aa-4f60-87b5-46fd00555c42/