# China NMPA Product Recall - Bone marrow biopsy needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/carefusion/8bfb8767-8330-42c6-8133-67d3d3f1d661
Source feed: China

> China NMPA product recall for Bone marrow biopsy needle by CareFusion published March 17, 2017. Recall level: Level II. Kangfusheng (Shanghai) Trading Co., Ltd., the responsible unit in China for manufacturer CareFusion 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Kangerfusheng (Shanghai) Trading Co., Ltd. voluntarily recalls bone marrow biopsy needles
- Company Name: CareFusion
- Publication Date: 2017-03-17
- Product Name: Bone marrow biopsy needle
- Recall Level: Level II
- Recall Reason: The product's aseptic packaging is defective, which cannot guarantee the product's sterility and may lead to local or systemic infection in users.
- Discovering Company: Kangerfusheng (Shanghai) Trading Co., Ltd.
- Manufacturing Company: CareFusion
- Summary: Kangfusheng (Shanghai) Trading Co., Ltd., the responsible unit in China for manufacturer CareFusion (now part of BD), initiated a voluntary Class II recall of specific bone marrow biopsy needles. The recall, reported on February 23, 2017, and published by the National Medical Products Administration (NMPA) on March 17, 2017, addresses a critical defect: compromised sterile packaging. This defect cannot guarantee the product's sterility, posing a risk of local or systemic infections for users. While the issue is visually identifiable before use, and no serious injuries have been reported globally or in China, the potential for harm prompted this action under the NMPA's regulatory oversight for imported medical devices. Required actions include the immediate discarding of all unshipped affected inventory and notifying customers to return previously shipped and sold products to CareFusion's warehouse for proper disposal. This measure ensures patient safety by removing potentially non-sterile devices from circulation.

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