# China NMPA Product Recall - Absorbable surgical sutures

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-medical-shanghai-international-trading-co-ltd/c5280f9c-3444-4de8-b3fa-7f68dca008dc/
Source feed: China

> China NMPA product recall for Absorbable surgical sutures by B. Braun Medical (Shanghai) International Trading Co., Ltd. published July 14, 2017. 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 with needles.
- Company Name: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: Absorbable surgical sutures
- Recall Level: Level 3 Recall
- Recall Reason: The product's thread connection strength test results did not meet the standards.
- 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 with needles, as announced by the National Medical Products Administration (NMPA) on July 14, 2017. The recall was prompted by internal testing, which revealed that the needle connection strength of certain product batches failed to meet established quality standards. This critical manufacturing deviation affected products registered under No.: 20143653379. A Class III recall indicates that the use of or exposure to the non-compliant product is not likely to cause adverse health consequences. The company reported the issue, with detailed information regarding specific models, specifications, and batch numbers available in the "Medical Device Recall Event Report Form" accessible through the NMPA website. This action highlights the NMPA's regulatory oversight in ensuring medical device safety and manufacturers' responsibility to adhere to product quality specifications. B. Braun Medical (Shanghai) International Trading Co., Ltd. undertook this recall to address the identified product deficiency and maintain compliance with medical device regulations.

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