# China NMPA Product Recall - Nerve and muscle stimulators

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-tarissa-health-technology-co-ltd/0df6323a-f47f-4e73-9101-2aa0d3313e15/
Source feed: China

> China NMPA product recall for Nerve and muscle stimulators by Shanghai Tarissa Health Technology Co., Ltd. published April 24, 2015. Recall level: Level III. Shanghai Tarisar Health Technology Co., Ltd. initiated a Class III voluntary recall of its TERESA-0 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Tarissa Health Technology Co., Ltd. initiates voluntary recall of neurostimulators.
- Company Name: Shanghai Tarissa Health Technology Co., Ltd.
- Publication Date: 2015-04-24
- Product Name: Nerve and muscle stimulators
- Recall Level: Level III
- Recall Reason: Due to management negligence, Shanghai Teresa Health Technology Co., Ltd. produced products without completing all changes to the product registration information during a series of processes, including relocation of registered address and production address, business registration, production license, and TERESA-0 type nerve and muscle stimulator product registration certificate. Furthermore, the company failed to promptly replace the labels, resulting in discrepancies between the actual production address, registered address, and other information on the product packaging and registration certificate. The product labeling also failed to meet the requirements of the State Food and Drug Administration Order No. 6, "Regulations on the Management of Instructions and Labels for Medical Devices," and the "Regulations on the Supervision and Administration of Medical Devices." This may cause confusion for users regarding product registration information.
- Discovering Company: Shanghai Tarissa Health Technology Co., Ltd.
- Manufacturing Company: Shanghai Tarissa Health Technology Co., Ltd.
- Summary: Shanghai Tarisar Health Technology Co., Ltd. initiated a Class III voluntary recall of its TERESA-0 Nerve and Muscle Stimulators on April 24, 2015, as reported to the National Medical Products Administration (NMPA). The recall stemmed from a management oversight where the company failed to update product labels following a relocation and changes to its registered and production addresses, as well as its business registration and product certification. The primary issue was a discrepancy between the addresses printed on the product labels and the actual operational locations, along with other outdated registration information. This non-compliance meant the product labeling did not meet the standards outlined in the State Food and Drug Administration Order No. 6, "Regulations on the Management of Instructions and Labels for Medical Devices," and the broader "Regulations on the Supervision and Administration of Medical Devices." These violations posed a risk of user confusion regarding the product's official registration details. To address these issues, Shanghai Tarisar Health Technology Co., Ltd. issued a recall notice to its customers, collected all affected units, and provided free, compliant replacement products. The recall involved 100 units, with 62 having been sold in Mainland China.

Company: https://www.globalkeysolutions.net/companies/shanghai-tarissa-health-technology-co-ltd/f46b5185-a9a0-4a8c-8f6e-9a0eae0cb440/