# China NMPA Product Recall - Absorbable surgical sutures (trade name: Novosyn)

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-medical-shanghai-international-trading-co-ltd/9b0990a4-f08a-40e0-aa41-a9f768ffd55e
Source feed: China

> China NMPA product recall for Absorbable surgical sutures (trade name: Novosyn) by B. Braun Medical (Shanghai) International Trading Co., Ltd. published April 29, 2019. Recall level: Level 3 Recall. B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class III recall o

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun Medical (Shanghai) International Trading Co., Ltd. is voluntarily recalling absorbable surgical sutures (trade name: Novosyn).
- Company Name: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2019-04-29
- Product Name: Absorbable surgical sutures (trade name: Novosyn)
- Recall Level: Level 3 Recall
- Recall Reason: Issues such as wire diameter failing inspection during product sampling
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Summary: B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class III recall of its absorbable surgical sutures, marketed under the trade name Novosyn, as announced by the National Medical Products Administration (NMPA) on April 29, 2019. This action, referenced under Shanghai Food and Drug Administration Recall No. 2019-097, was prompted by a significant quality control issue where the suture diameter failed product sampling inspection. The affected medical devices, registered under Certificate No. CFDA (Imported) 2013 No. 3652572, are detailed in a 'Medical Device Recall Event Report Form' that specifies the model, specifications, and batch numbers. This proactive recall demonstrates the company's adherence to regulatory standards enforced by the NMPA and the Shanghai Food and Drug Administration, ensuring product safety and quality within the medical device market. The recall requires relevant parties to consult the attached report for comprehensive details on the impacted products.

Company: https://www.globalkeysolutions.net/companies/b-braun-medical-shanghai-international-trading-co-ltd/58112c52-92f6-4aa8-acd6-c5efd892653b