# China NMPA Product Recall - Absorbable Surgical Suture with Needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-surgical-sa/d4042756-3d5d-4d2a-9a1f-a15aa47b681e/
Source feed: China

> China NMPA product recall for Absorbable Surgical Suture with Needle by B. Braun Surgical SA published July 18, 2022. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun Surgical SA, a Spanish medical company, is voluntarily recalling its Absorbable Surgical Suture with needles.
- Company Name: B. Braun Surgical SA
- Publication Date: 2022-07-18
- Product Name: Absorbable Surgical Suture with Needle
- Recall Level: Level 2 Recall
- Recall Reason: The degradation test results did not meet the product's technical specifications.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: B. Braun Surgical SA
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by B. Braun Surgical SA (Spain) for specific models and batches of its Absorbable Surgical Sutures with Needles. The recall, published on July 18, 2022, through B. Braun Medical (Shanghai) International Trading Co., Ltd., stems from a critical quality issue where product degradation test results failed to meet established technical specifications.

This non-compliance indicates a potential compromise in the sterility, strength, or absorption profile of the sutures, which could impact patient safety and surgical outcomes. The affected products are identifiable by Registration Certificate No.: 20163024884. While the document does not mention specific inspection dates, the action is a manufacturer-initiated voluntary recall to address the identified quality deficiency proactively.

As a required action, B. Braun Surgical SA is conducting a full recall of the implicated absorbable surgical sutures. Stakeholders, including healthcare providers and distributors, are directed to consult the 'Medical Device Recall Event Report Form' and the attached 'B. Braun Medical Spain S.A. Attachment.pdf' for comprehensive details regarding the specific models, specifications, and batch numbers affected by this recall.

Company: https://www.globalkeysolutions.net/companies/b-braun-surgical-sa/3550d86b-5eb2-43c2-a89f-ba6333293c76/