# China NMPA Product Recall - Floating tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-lifesciences-llc/1eeb0762-327c-4420-a99c-dacb9974ea8a/
Source feed: China

> China NMPA product recall for Floating tube by Edwards Lifesciences LLC published January 24, 2019. Recall level: Level 3 Recall. Edwards Lifesciences LLC initiated a voluntary Class III recall of its Floating Catheters (Registrat

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards Lifesciences LLC initiates voluntary recall of floating catheters
- Company Name: Edwards Lifesciences LLC
- Publication Date: 2019-01-24
- Product Name: Floating tube
- Recall Level: Level 3 Recall
- Recall Reason: The Australian regulatory team discovered that the floating tubing in question was being supplied to Australian customers without a TGA-approved certificate. Even after the TGA CA certificate expired on August 9, 2018, the floating tubing continued to be supplied within Australia, and the ARTG license was cancelled.
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards Lifesciences LLC
- Summary: Edwards Lifesciences LLC initiated a voluntary Class III recall of its Floating Catheters (Registration Certificate No.: 20163774711), as reported by Edwards (Shanghai) Medical Supplies Co., Ltd. through the National Medical Products Administration (NMPA) on January 24, 2019. This action, with the recall report filed on December 28, 2018, primarily addresses issues identified within the Australian market. The main violation was the continued supply of several models of floating catheters to Australian customers without a valid Therapeutic Goods Administration (TGA) approval certificate. Specifically, a crucial supporting document, the CA certificate, expired on August 9, 2018. This expiration led to the cancellation of the Australian Register of Therapeutic Goods (ARTG) license (160613) effective June 29, 2018, yet products continued to be distributed. The regulatory framework involved includes the NMPA overseeing the reporting agent in China and the TGA in Australia, where the non-compliance occurred. As a required action, the manufacturer is actively reapplying for ARTG market access permission. It is important to note that the affected products were not sold in China, meaning no specific corrective actions are required within the Chinese market, and the company confirmed no patient impact.

Company: https://www.globalkeysolutions.net/companies/edwards-lifesciences-llc/d78876e8-6a4a-49b4-8cb5-30579a7ed097/