# China NMPA Product Recall - Medical temperature control blanket

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-dawei-tongchuang-medical-equipment-co-ltd/197e4c59-e801-42e9-b610-043d3ea9f9a5/
Source feed: China

> China NMPA product recall for Medical temperature control blanket by Beijing Dawei Tongchuang Medical Equipment Co., Ltd. published October 17, 2017. Recall level: Level 3 Recall. Beijing Dawei Tongchuang Medical Equipment Co., Ltd. initiated a voluntary Level III recall of its M

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing Dawei Tongchuang Medical Equipment Co., Ltd. voluntarily recalls medical temperature-controlled blankets.
- Company Name: Beijing Dawei Tongchuang Medical Equipment Co., Ltd.
- Publication Date: 2017-10-17
- Product Name: Medical temperature control blanket
- Recall Level: Level 3 Recall
- Recall Reason: The production license number “京药监械生产许20030002号” on the label and instructions of the medical temperature control blanket should be “京食药监械生产许20030002号”.
- Discovering Company: Beijing Dawei Tongchuang Medical Equipment Co., Ltd.
- Manufacturing Company: Beijing Dawei Tongchuang Medical Equipment Co., Ltd.
- Summary: Beijing Dawei Tongchuang Medical Equipment Co., Ltd. initiated a voluntary Level III recall of its Medical Temperature Control Blankets, specifically model DWK-II (batches DWK-IIC09001-DWK-IIC09020, affecting 20 units in China). The company reported the issue on October 1, 2017, with the recall publicly announced by the National Medical Products Administration (NMPA) on October 17, 2017. The primary issue discovered by the company was an incorrect production license number printed on the product labels and instructions for use. The erroneous number "京药监械生产许20030002号" was used instead of the correct "京食药监械生产许20030002号". This discrepancy, while a regulatory non-compliance under the NMPA framework, has been confirmed to be unrelated to the safety or performance of the medical devices. As required actions, Beijing Dawei Tongchuang Medical Equipment Co., Ltd. is notifying affected customers via email. Furthermore, the company will deploy engineers or authorized distributors to correct the non-compliance on all affected products at no cost. This correction involves physically replacing the incorrect labels with updated versions and amending or covering the erroneous content within the product instructions to ensure full regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/beijing-dawei-tongchuang-medical-equipment-co-ltd/99dc1443-3b4c-4910-8326-90e5237cfae7/