# China NMPA Product Recall - Self-adhesive dressing

Source: https://www.globalkeysolutions.net/records/china_product_recall/minnesota-mining-manufacturing-medical-devices-shanghai-co-ltd/eb96f222-7d2c-4d25-aa24-72de8c63fec9/
Source feed: China

> China NMPA product recall for Self-adhesive dressing by Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. published February 21, 2017. Recall level: Level III. Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. initiated a Class III voluntary 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its self-adhesive dressings.
- Company Name: Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd.
- Publication Date: 2017-02-21
- Product Name: Self-adhesive dressing
- Recall Level: Level III
- Recall Reason: The products were found to lack a production date, which does not comply with the new "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration), which requires product labels to include a production date. Therefore, it has been decided to recall the affected products.
- Discovering Company: Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd.
- Summary: Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. initiated a Class III voluntary recall of its self-adhesive dressings, as reported by the National Medical Products Administration (NMPA) on February 21, 2017. The primary violation involved product labels lacking production dates, affecting batches produced between August and December 2016. This non-compliance breaches the new "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration), which mandates the inclusion of production dates on medical device labels. In response, the company has undertaken several corrective actions. They formally notified affected customers and are actively collecting and relabeling products through returns and exchanges to ensure all items on the market display the required production date. Furthermore, Minnesota Mining Manufacturing Medical Devices (Shanghai) Co., Ltd. is implementing a label change process to update label content to meet regulatory standards. To prevent future recurrences, a "Label Approval Management System" (QAP1301) has been developed, and associated training conducted. The company also committed to providing regular progress reports on the recall to the Shanghai Food and Drug Administration.

Company: https://www.globalkeysolutions.net/companies/minnesota-mining-manufacturing-medical-devices-shanghai-co-ltd/ae45d687-fda6-45c4-a54b-3fd4bcbfd852/