# China NMPA Product Recall - Nasal mucosal nebulizer spray drug delivery device and laryngeal mucosal nebulizer spray drug delivery device

Source: https://www.globalkeysolutions.net/records/china_product_recall/wolfe-tory-medical-inc/c64dd787-b809-4843-ac60-0abfdfa75704/
Source feed: China

> China NMPA product recall for Nasal mucosal nebulizer spray drug delivery device and laryngeal mucosal nebulizer spray drug delivery device by Wolfe Tory Medical, Inc. published December 05, 2016. Recall level: . The National Medical Products Administration (NMPA) issued a notice regarding a voluntary global rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Wolfe Tory Medical, Inc. is recalling nasal nebulizers and laryngeal nebulizers.
- Company Name: Wolfe Tory Medical, Inc.
- Publication Date: 2016-12-05
- Product Name: Nasal mucosal nebulizer spray drug delivery device and laryngeal mucosal nebulizer spray drug delivery device
- Recall Reason: These products deliver local anesthesia to the mucous membranes of the mouth, nose, pharynx, or larynx via a nebulized spray. Talifo Medical is recalling these products because they may produce a direct flow of fluid instead of complete nebulization. Serious adverse health consequences are unlikely in cases of nebulization failure, but may result in inadequate local anesthesia and discomfort, requiring further attempts at local anesthesia or the use of alternative methods.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Wolfe Tory Medical, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a notice regarding a voluntary global recall initiated by Wolfe Tory Medical, Inc. for its Nasal Nebulizer and Laryngeal Nebulizer Drug Delivery Devices (CFDA (Imported) 2013 No. 2665110 and No. 2665111). The recall, reported on November 3 and 6, 2016, and published by NMPA on December 5, 2016, addresses a critical issue where the devices may deliver a direct liquid flow instead of the intended complete nebulization. This malfunction could lead to insufficient local anesthesia, causing patient discomfort, although serious adverse health consequences are deemed unlikely. Wolfe Tory Medical Devices Trading (Shanghai) Co., Ltd., the responsible unit in China, confirmed that the affected products were neither imported into nor sold within mainland China. Consequently, no direct corrective actions are required domestically. However, the NMPA requested provincial food and drug administrations to enhance supervision and management of similar products to ensure public safety. The recall highlights the manufacturer's responsibility under regulatory frameworks to address product performance deviations impacting patient experience.

Company: https://www.globalkeysolutions.net/companies/wolfe-tory-medical-inc/0dac6055-ed34-4ae8-8419-5722710e3c23/