# China NMPA Product Recall - Frova Intubating Introducer

Source: https://www.globalkeysolutions.net/records/china_product_recall/william-cook-europe-aps/8f6a83c7-8a6d-418a-aee9-34d1a1bc5476/
Source feed: China

> China NMPA product recall for Frova Intubating Introducer by William Cook Europe ApS published July 27, 2021. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: William Cook Europe ApS is voluntarily recalling its Frova Intubating Introducer cannula.
- Company Name: William Cook Europe ApS
- Publication Date: 2021-07-27
- Product Name: Frova Intubating Introducer
- Recall Level: Level 2 Recall
- Recall Reason: There is an issue with a hardened sleeve provided by an internal product error.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: William Cook Europe ApS
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by William Cook Europe ApS for its Frova Intubating Introducer, as reported by Cook (China) Medical Trading Co., Ltd. on July 27, 2021. The recall stems from a critical manufacturing issue where specific models and batches of the medical device were found to contain an incorrect hardened cannula. This defect could potentially compromise the product's intended function and patient safety during airway management procedures. The NMPA serves as the regulatory authority overseeing medical device compliance and safety within China, providing the framework for such recall actions. While the document does not specify inspection dates, the company's proactive voluntary recall reflects its commitment to addressing product quality concerns under NMPA's guidance. Affected users are directed to consult the "Medical Device Report Form" for detailed information regarding the specific product models, specifications, and batch numbers involved, to ensure proper identification and removal of the non-conforming devices from circulation.

Company: https://www.globalkeysolutions.net/companies/william-cook-europe-aps/fba74465-d39c-4165-85c2-2bf10ad84425/