# China NMPA Product Recall - Disposable sterile urinary catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/wellspect-healthcare-a-division-of-dentsply-ih-ab/b234b598-50a9-48b5-92a1-4d37f04150fc/
Source feed: China

> China NMPA product recall for Disposable sterile urinary catheter by Wellspect HealthCare (a division of Dentsply IH AB) published June 29, 2020. Recall level: Level 2 Recall. Dentsply Sirona Dental Products (Shanghai) Co., Ltd., on June 29, 2020, initiated a voluntary Class 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dentsply Sirona Dental Products (Shanghai) Co., Ltd. has initiated a voluntary recall of disposable sterile urinary catheters.
- Company Name: Wellspect HealthCare (a division of Dentsply IH AB)
- Publication Date: 2020-06-29
- Product Name: Disposable sterile urinary catheter
- Recall Level: Level 2 Recall
- Recall Reason: The products in question have issues such as damaged tips that are stuck in sealed packaging.
- Discovering Company: Dentsply Sirona Dental Products (Shanghai) Co., Ltd.
- Manufacturing Company: Wellspect HealthCare (a division of Dentsply IH AB)
- Summary: Dentsply Sirona Dental Products (Shanghai) Co., Ltd., on June 29, 2020, initiated a voluntary Class II recall of its disposable sterile urinary catheters. The manufacturer, Wellspect HealthCare (a division of Dentsply IH AB), discovered during routine sampling that the product's tip was damaged and lodged within its sealed packaging. This critical defect compromises the sterility and functionality of the medical device, posing potential risks to patient safety and treatment efficacy. The recall action is overseen by the National Medical Products Administration (NMPA) and was reported via the Shanghai Municipal Drug Administration. A Class II recall is typically enacted when a product may cause temporary or reversible adverse health consequences, or when the probability of serious adverse health consequences is remote, emphasizing the need for corrective measures. While specific inspection dates are not detailed in the document, the issue was identified through established quality control protocols. Dentsply Sirona Dental Products (Shanghai) Co., Ltd. is responsible for implementing the recall, ensuring the removal of all affected models, specifications, and batches from the market. Comprehensive details regarding the involved products are provided in an attached Medical Device Recall Event Report Form. This action reflects the company's commitment to upholding product quality and adhering to stringent regulatory standards established by the NMPA.

Company: https://www.globalkeysolutions.net/companies/wellspect-healthcare-a-division-of-dentsply-ih-ab/41457842-3128-46bb-8d2c-cc0145ad6382/