# China NMPA Product Recall - sterilizer

Source: https://www.globalkeysolutions.net/records/china_product_recall/getinge-sterilization-ab/e0d77abb-7ae1-4b61-9409-1d2e92ab0228/
Source feed: China

> China NMPA product recall for sterilizer by Getinge Sterilization AB published January 13, 2017. Recall level: Level III. Getinge Trading (Shanghai) Co., Ltd., the responsible unit in China for manufacturer Getinge Sterili

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jieding Trading (Shanghai) Co., Ltd. voluntarily recalls sterilizers
- Company Name: Getinge Sterilization AB
- Publication Date: 2017-01-13
- Product Name: sterilizer
- Recall Level: Level III
- Recall Reason: Some HS66 series sterilizers used expired product registration numbers on their Chinese labels, which does not comply with the regulations of the State Food and Drug Administration.
- Discovering Company: Jieding Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Getinge Sterilization AB
- Summary: Getinge Trading (Shanghai) Co., Ltd., the responsible unit in China for manufacturer Getinge Sterilization AB, initiated a voluntary Level III recall for its HS66 series sterilizers, including models HS6613, HS6617, and HS6620. This recall was reported on November 28, 2016, and publicly announced on January 13, 2017. The primary issue involved 59 units distributed in Mainland China which were found to have Chinese labels displaying expired product registration certificate numbers. While new registration certificates had been obtained for subsequent products, the labels on the affected sterilizers did not meet the regulatory requirements of the State Food and Drug Administration (now the National Medical Products Administration). Importantly, Getinge confirmed that this labeling discrepancy did not pose any safety risk to operators or patients. To address this non-compliance, Getinge Trading (Shanghai) Co., Ltd. committed to notifying all affected users and implementing on-site corrective actions. These actions involve personnel removing the incorrect Chinese labels and replacing them with accurate, updated versions to ensure full adherence to Chinese medical device regulations.

Company: https://www.globalkeysolutions.net/companies/getinge-sterilization-ab/7e0cd868-6669-4b2a-a346-22a9c42d803f/