# China NMPA Product Recall - Angiography catheter, embolization coil, TAO Brush® I.U.M.C. endometrial sampler, microcatheter, embolization coils, wire guides

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/7f814370-d8f6-4832-b912-8de84402dfe3/
Source feed: China

> China NMPA product recall for Angiography catheter, embolization coil, TAO Brush® I.U.M.C. endometrial sampler, microcatheter, embolization coils, wire guides by Cook Incorporated published October 15, 2021. Recall level: . Cook Incorporated initiated a voluntary recall of several medical devices, as documented by the Nati

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated is voluntarily recalling medical devices including the Angiography Catheter.
- Company Name: Cook Incorporated
- Publication Date: 2021-10-15
- Product Name: Angiography catheter, embolization coil, TAO Brush® I.U.M.C. endometrial sampler, microcatheter, embolization coils, wire guides
- Recall Reason: Because certain models and batches of products were involved, and some were removed from the EU Declaration of Conformity, these specific batches were still sold to Europe, the Middle East, and Africa.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook Incorporated initiated a voluntary recall of several medical devices, as documented by the National Medical Products Administration (NMPA) on October 15, 2021. The recall stems from an issue where specific models and batches of products, despite being removed from the EU Declaration of Conformity, were inadvertently distributed to markets including Europe, the Middle East, and Africa. This represents a significant regulatory compliance deviation.

The affected medical devices encompass a range of critical products, including Angiography Catheters, Embolization Coils, TAO Brush® Endometrial Sampler, I.U.M.C. Endometrial Sampler, Microcatheters, and Wire Guides. Each recalled product is identified by specific registration certificates (e.g., 20173770705 for Angiography Catheter), with detailed batch and specification information available in the accompanying "Medical Device Recall Event Report Form."

This action, published by the NMPA, signifies a proactive measure by Cook (China) Medical Trading Co., Ltd. to address the non-conformance. The required action involves a voluntary recall to mitigate potential risks associated with these products, ensuring they meet all necessary declarations and standards for their respective markets. Companies are obligated to identify and retrieve all affected products from distribution channels to uphold product safety and maintain regulatory adherence.

Company: https://www.globalkeysolutions.net/companies/cook-incorporated/1824e76a-038e-4220-8016-501448925cf2/