# China NMPA Product Recall - 2ml of surgical sealant

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-medical-supplies-trading-shanghai-co-ltd/a98ab68a-e67c-4d65-bb8b-1bf63420f71c/
Source feed: China

> China NMPA product recall for 2ml of surgical sealant by Baxter Medical Supplies Trading (Shanghai) Co., Ltd. published May 28, 2021. Recall level: Level 3 Recall. Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its 2

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baxter Medical Supplies Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of surgical occlusives.
- Company Name: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-05-28
- Product Name: 2ml of surgical sealant
- Recall Level: Level 3 Recall
- Recall Reason: The English sticker label inside the product packaging box incorrectly prints the product specification as 8ml (it should actually be 2ml), while the Chinese sticker label outside the box shows the correct specification as 2ml.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Summary: Baxter Medical Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its 2ml surgical sealant (Registration Certificate No.: 
国械注进20193022073) on May 28, 2021. This action was prompted by a critical packaging discrepancy affecting product integrity and user information. The primary issue involved an incorrect English sticker label inside the product box, which mistakenly indicated a product specification of 8ml, contrasting with the actual 2ml volume. Conversely, the Chinese sticker label affixed to the exterior of the box accurately displayed the 2ml specification. This labeling error posed a risk of confusion regarding the actual product volume, potentially impacting proper medical use. The recall, indexed as JGXX-2021-10262 and published by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, underscores the company’s commitment to product safety and compliance with regulatory standards. The company has taken the required action of recalling affected batches to rectify the discrepancy and ensure all product information is accurate and consistent across all packaging elements. Further details on specific models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form" associated with this announcement.

Company: https://www.globalkeysolutions.net/companies/baxter-medical-supplies-trading-shanghai-co-ltd/6683d881-f097-4ad4-8c0e-86927dfa203a/