# China NMPA Product Recall - Disposable suction pack

Source: https://www.globalkeysolutions.net/records/china_product_recall/suzhou-mclean-medical-device-products-co-ltd/2a08ef46-a161-4657-a143-69674dd325fd/
Source feed: China

> China NMPA product recall for Disposable suction pack by Suzhou McLean Medical Device Products Co., Ltd. published December 31, 2019. Recall level: Level 3 Recall. Suzhou McLean Medical Device Products Co., Ltd. has initiated a voluntary Class III recall of its di

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Suzhou McLean Medical Device Products Co., Ltd. has voluntarily recalled its disposable suction packs.
- Company Name: Suzhou McLean Medical Device Products Co., Ltd.
- Publication Date: 2019-12-31
- Product Name: Disposable suction pack
- Recall Level: Level 3 Recall
- Recall Reason: In the 2019 national medical device spot check, the residual vacuum index exceeded the tolerance due to the smaller inner lumen size of the suction catheter connector.
- Discovering Company: Suzhou McLean Medical Device Products Co., Ltd.
- Manufacturing Company: Suzhou McLean Medical Device Products Co., Ltd.
- Summary: Suzhou McLean Medical Device Products Co., Ltd. has initiated a voluntary Class III recall of its disposable suction kits. This action follows findings from a 2019 national medical device spot check, which identified a critical issue with the product. The primary violation involved the suction tube connector having a smaller than expected inner diameter. This manufacturing defect resulted in excessive residual vacuum, posing a potential risk to users. The recall, overseen by the National Medical Products Administration (NMPA) as part of its regulatory framework for medical device safety, targets specific models, specifications, and batch numbers of the disposable suction kits, as detailed in the "Medical Device Report Form." The company's proactive voluntary recall demonstrates adherence to regulatory requirements and a commitment to product quality and patient safety, addressing the identified non-conformity to prevent further distribution of affected devices.

Company: https://www.globalkeysolutions.net/companies/suzhou-mclean-medical-device-products-co-ltd/5b91ac88-d4d3-49de-bf7b-572d609b4c24/