# China NMPA Product Recall - Hydrophilic coated guidewire

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/0cf1f8d5-471c-41d4-a672-da6a0a276ca3/
Source feed: China

> China NMPA product recall for Hydrophilic coated guidewire by Cook Incorporated published August 30, 2016. Recall level: Level 2 Recall. Cook (China) Medical Trading Co., Ltd. has initiated a voluntary Level II recall of specific Hydroph

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook (China) Medical Trading Co., Ltd. voluntarily recalls hydrophilic coated guidewires
- Company Name: Cook Incorporated
- Publication Date: 2016-08-30
- Product Name: Hydrophilic coated guidewire
- Recall Level: Level 2 Recall
- Recall Reason: DSM Biomedical B.V. of the Netherlands is a raw material supplier for this product. Cook Medical Inc. of the United States was notified on June 14, 2016, that the raw material supplier had initiated a recall of DSM substrate P41002 and hydrophilic coating TC43003. The primary reason for the recall is the potential risk of glass fragment contamination (glass fragment size approximately 4-280µm). As the legally authorized manufacturer of the medical device, Cook Medical Inc. immediately initiated a corresponding investigation and a global voluntary recall of certain batches of products across 15 models affected by the contaminated raw material. This product recall is a Level II recall. Due to the potential contamination from the glass fragments, the following potential adverse events may occur: vascular injury, bleeding, and the detection of particles in the circulatory system. To date, Cook Medical Inc. has not received any reports of patient injuries or illnesses related to this issue. Cook Medical (China) Co., Ltd. has never received any adverse events or customer complaints regarding this product within China.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook (China) Medical Trading Co., Ltd. has initiated a voluntary Level II recall of specific Hydrophilic Coated Guidewires in China, as reported to the National Medical Products Administration (NMPA) on August 30, 2016. The recall stems from a notification received on June 14, 2016, from raw material supplier DSM Biomedical B.V., indicating contamination by glass fragments (ranging from 4-280µm) in critical materials, specifically DSM substrate P41002 and hydrophilic coating TC43003. This contamination impacted 15 batches across several guidewire models. Of the 421 boxes imported into China, 331 had been sold. Although no patient injuries or adverse events related to this issue have been reported, the presence of glass fragments in the guidewires, which are used to assist in peripheral vascular catheter delivery, poses potential health risks including vascular injury, bleeding, and the introduction of particles into the circulatory system. Under NMPA regulations, Cook (China) Medical Trading Co., Ltd. is responsible for the recall within the country. Required actions include notifying distributors in writing within three days to return all unused affected products. Distributors are also mandated to inform their client institutions. Cook (China) will destroy the recalled devices and provide appropriate compensation. For patients who have already used the product without experiencing adverse events, no special medical follow-up is deemed necessary.

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