# China NMPA Product Recall - chorionic villus sampling needle kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/william-a-cook-australia-pty-ltd/dbca0430-e613-4a42-be27-183b713ee5d4/
Source feed: China

> China NMPA product recall for chorionic villus sampling needle kit by William A. Cook Australia, Pty. Ltd. published July 12, 2018. Recall level: Level 3 Recall. William A. Cook Australia, Pty. Ltd., in conjunction with its Chinese entity, COOK (China) Medical T

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: William A. Cook Australia, Pty. Ltd. voluntarily recalls vibratory biopsy kits.
- Company Name: William A. Cook Australia, Pty. Ltd.
- Publication Date: 2018-07-12
- Product Name: chorionic villus sampling needle kit
- Recall Level: Level 3 Recall
- Recall Reason: The English labeling of the recalled products indicates that the 18GA guide needle tip is radiopaque and the 21GA sampling needle tip is non-radiopaque; however, this labeling is incorrect. According to the product design requirements, the 21GA sampling needle should have a radiopaque tip and the 18GA guide needle a non-radiopaque tip. Even if the non-radiopaque tip of a larger diameter guide needle (18GA, the smaller the number, the larger the diameter) is not radiopaque, it is easily visible under ultrasound. Therefore, the risk associated with the labeling error is extremely low. The labeling error is unlikely to cause adverse events. Correcting the English labeling will not affect the normal production process of the product tip imaging. It has no impact on the product itself; it is merely a labeling error.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: William A. Cook Australia, Pty. Ltd.
- Summary: William A. Cook Australia, Pty. Ltd., in conjunction with its Chinese entity, COOK (China) Medical Trading Co., Ltd., issued a voluntary Class III recall on July 2, 2018, as reported by the National Medical Products Administration (NMPA) on July 12, 2018. The recall pertains to specific batches of Villus Microscopy Needle Kits (Registration Certificate No.: 20153150273) manufactured before June 4, 2018. The primary issue identified was a labeling error on the product's English packaging. The label incorrectly stated that the 18-gauge guide needle tip was radiopaque and the 21-gauge sampling needle tip was non-radiopaque. According to the product's design specifications, the 21-gauge sampling needle should be radiopaque, and the 18-gauge guide needle non-radiopaque. Despite this discrepancy, the company assessed the risk as extremely low. The larger 18-gauge guide needle remains easily visible under ultrasound even without a radiopaque tip, and the labeling error does not impact the product's functionality or tip angiography process. Consequently, it is deemed unlikely to cause adverse patient events. Operating under the oversight of the NMPA, the recall was initiated globally. However, COOK (China) Medical Trading Co., Ltd. confirmed that no affected batches of these Villus Microscopy Needle Kits were imported or distributed within the Chinese market. Therefore, no specific actions or handling measures were required for products in China.

Company: https://www.globalkeysolutions.net/companies/william-a-cook-australia-pty-ltd/f77e2b4c-b80a-444b-9265-26f47dffe569/