# China NMPA Product Recall - guide wire

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-shanghai-co-ltd/c57ab613-e8f1-4336-bc5e-93161804d8b5/
Source feed: China

> China NMPA product recall for guide wire by Abbott Medical (Shanghai) Co., Ltd. published March 17, 2020. Recall level: Level 3 Recall. On March 17, 2020, Abbott Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III reca

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Medical Products (Shanghai) Co., Ltd. voluntarily recalls guidewires.
- Company Name: Abbott Medical (Shanghai) Co., Ltd.
- Publication Date: 2020-03-17
- Product Name: guide wire
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue with incorrect production address on the Chinese labels of certain batch numbers.
- Discovering Company: Abbott Medical (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Medical (Shanghai) Co., Ltd.
- Summary: On March 17, 2020, Abbott Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific batches of its guidewire products. The company identified an error regarding the production address printed on the Chinese labels of these medical devices. This voluntary action was taken under the regulatory framework of the National Medical Products Administration (NMPA) and was reported through the Shanghai Municipal Drug Administration, identified by index number 沪药监械主召2020-058. The affected guidewires are registered under Certificate No. 国械注进20163773310. No specific inspection dates were mentioned, as the recall was company-initiated to address the labeling discrepancy. Abbott Medical Products (Shanghai) Co., Ltd. is required to remove the non-compliant products from circulation, with detailed information on the affected models, specifications, and batch numbers available in the associated "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/abbott-medical-shanghai-co-ltd/c4208c4e-424f-4bd5-9c27-c8d650c64287/