# China NMPA Product Recall - Bone marrow biopsy needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/carefusion/52f2161f-1678-41ee-aa59-6e66cb2f9004/
Source feed: China

> China NMPA product recall for Bone marrow biopsy needle by CareFusion published August 27, 2019. Recall level: Level 2 Recall. CareFusion (Shanghai) Trading Co., Ltd., in collaboration with its manufacturer, CareFusion, announc

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: CareFusion initiates voluntary recall of bone marrow biopsy needles.
- Company Name: CareFusion
- Publication Date: 2019-08-27
- Product Name: Bone marrow biopsy needle
- Recall Level: Level 2 Recall
- Recall Reason: The product in question may have been improperly sealed.
- Discovering Company: Kangerfusheng (Shanghai) Trading Co., Ltd.
- Manufacturing Company: CareFusion
- Summary: CareFusion (Shanghai) Trading Co., Ltd., in collaboration with its manufacturer, CareFusion, announced a voluntary Class II recall of specific bone marrow biopsy needles. This significant action, reported by the National Medical Products Administration (NMPA) on August 27, 2019, was prompted by a critical manufacturing concern: a potential issue of improper sealing within the affected devices (Registration Certificate No.: 20163152800). The defect involving improper sealing could compromise the sterility or functionality of the bone marrow biopsy needles, posing potential risks to patients undergoing procedures. Recognizing the gravity of such an an issue, CareFusion proactively initiated this recall to mitigate any health hazards. A Class II recall, as designated by regulatory bodies like the NMPA, indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company has made detailed information regarding the specific models, specifications, and batch numbers of the affected products available in the "Medical Device Recall Event Report Form." This document is crucial for healthcare providers and distributors to identify and isolate the recalled items effectively. This voluntary recall demonstrates CareFusion's commitment to upholding product quality and patient safety standards, aligning with NMPA's regulatory oversight to ensure only safe and effective medical devices are utilized in clinical settings.

Company: https://www.globalkeysolutions.net/companies/carefusion/1bd34fdc-7715-4658-9797-4ad2dccf85b9/