# China NMPA Product Recall - Needle holder; Microscopic scissor; Suction tube; Microscopic tweezer; Cardio-Vascular Surgical Instruments; Disposable bipolar electrocoagulation forceps; Bipolar electrocoagulation forceps; Bipolar electrocoagulation surgical forceps; Neurosurgical Instruments; Bipolar electrocoagulation surgical forceps

Source: https://www.globalkeysolutions.net/records/china_product_recall/aesculap-ag/fdab3baa-f20d-4100-8cfd-7d51accea987
Source feed: China

> China NMPA product recall for Needle holder; Microscopic scissor; Suction tube; Microscopic tweezer; Cardio-Vascular Surgical Instruments; Disposable bipolar electrocoagulation forceps; Bipolar electrocoagulation forceps; Bipolar electrocoagulation surgical forceps; Neurosurgical Instruments; Bipolar electrocoagulation surgical forceps by Aesculap AG published March 16, 2020. 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 the following instruments: needle holder, microscopic scissor, suction tube, microscopic tweezer, cardio-vascular surgical instruments, disposable bipolar electrocoagulation forceps, bipolar electrocoagulation forceps, bipolar electrocoagulation surgical forceps, neurosurgical instruments, and bipolar electrocoagulation surgical forceps.
- Company Name: Aesculap AG
- Publication Date: 2020-03-16
- Product Name: Needle holder; Microscopic scissor; Suction tube; Microscopic tweezer; Cardio-Vascular Surgical Instruments; Disposable bipolar electrocoagulation forceps; Bipolar electrocoagulation forceps; Bipolar electrocoagulation surgical forceps; Neurosurgical Instruments; Bipolar electrocoagulation surgical forceps
- Recall Level: Level 3 Recall
- Recall Reason: The product classification of some surgical instruments has changed in the EU, and the descriptions of the reprocessing procedures (cleaning, disinfection, sterilization) of surgical instruments in the instruction manuals have been modified accordingly.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Aesculap AG
- Summary: B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class III recall on March 16, 2020, as reported by the National Medical Products Administration (NMPA) and Shanghai Drug Administration. The recall concerns various surgical instruments, including needle holders, microscopic scissors, suction tubes, and bipolar electrocoagulation forceps. The core issue arose from changes in product classification within the European Union, which led to necessary modifications in the reprocessing procedures (cleaning, disinfection, sterilization) detailed in the instruments' instructions for use. The manufacturer, Aesculap AG, assessed that these updated reprocessing procedures would not increase patient risk. The regulatory framework underscores adherence to local medical device regulations, with this recall being a proactive safety information dissemination. The primary required action for B. Braun Medical (Shanghai) is to issue customer notifications describing these corrective measures for user reference. Notably, this recall is solely for product safety information and does not involve the return of any affected products, emphasizing that medical institutions must continue to follow local regulations for surgical instrument reprocessing.

Company: https://www.globalkeysolutions.net/companies/aesculap-ag/59485d99-dc5a-4710-8d68-32cd0df59fe2