# China NMPA Product Recall - Bone marrow biopsy needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/vidacare-corporation/ede045d2-3363-42bb-80fb-826bb3cb92cf/
Source feed: China

> China NMPA product recall for Bone marrow biopsy needle by Vidacare Corporation published December 05, 2016. Recall level: . Vidacare Corporation, the manufacturer, initiated a global voluntary recall of its bone marrow biops

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Vidacare Corporation recalls bone marrow biopsy needles
- Company Name: Vidacare Corporation
- Publication Date: 2016-12-05
- Product Name: Bone marrow biopsy needle
- Recall Reason: The outer sterile packaging may have an incomplete seal, which could compromise the sterility of the inner drape and create a potential for infection.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Vidacare Corporation
- Summary: Vidacare Corporation, the manufacturer, initiated a global voluntary recall of its bone marrow biopsy needles, distributed by Teleflex Medical Devices Trading (Shanghai) Co., Ltd. The National Medical Products Administration (NMPA) published this recall on December 5, 2016, following Teleflex's report on November 10, 2016. The primary issue involved potential defects in the outer sterile packaging of the bone marrow biopsy needles (NMPA Registration Certificate No.: CFDA (Imported) No. 20143154576). This packaging flaw could compromise the sterility of the internal drape used for bone marrow aspiration preparation, thereby posing a risk of infection to patients. Under the NMPA's regulatory oversight, the recall was initiated globally. Crucially, Vidacare Corporation confirmed that the affected product batches were neither imported into nor sold in mainland China. Consequently, no specific corrective actions were required within China. However, the NMPA instructed provincial food and drug administrations to enhance supervision of such medical devices. The recall addresses a critical safety concern regarding medical device sterility.

Company: https://www.globalkeysolutions.net/companies/vidacare-corporation/25147eeb-f985-4c7a-8bb4-f80212aced97/